A First in Human Study to Evaluate the Safety, Tolerabili... | NCT02195349

ID	Type	Description	Link
2014-000312-33	EudraCT Number

Name	Class
Parexel	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy Subjects (no DTH)	Experimental	One subject will be dosed with GSK2831781 (0.0003 mg/kg) and one with placebo. Depending on the safety data obtained for 28 days post dose along with the available PK data, a dose escalation may be done to the next planned dose (0.0015 , 0.0075, 0.04, 0.15 mg/kg). In case safety findings are noted then the cohort may be expanded to a maximum cohort size of 6:3 (GSK2831781: placebo) or the escalation will be stopped.	Biological: GSK2831781 Biological: Placebo
Healthy Subjects (DTH)	Experimental	Sentinel subjects (one dosed with GSK2831781 (0.0003 mg/kg) and one with placebo) will be used in the cohort. Following a review of safety data up to 48 hours post dose, an additional 5 active (GSK2831781) and 1 placebo subject will be dosed (no more than 2 subjects per day with dosing separated by at least 1 hour). After reviewing the safety data for 28 days the healthy subjects (DTH) will be escalated to the planned dose of GSK2831781 (0.0075, 0.04, 0.15 mg/kg) in 6:3 ratio with placebo.	Biological: GSK2831781 Biological: Placebo
Subjects with Psoriasis	Experimental	Sentinel subjects (one dosed with GSK2831781 and one with placebo) will be used in the cohort. Following a review of safety data up to 48 hours post dose, an additional 5 active (GSK2831781) and 2 placebo subjects will be dosed (no more than 2 subjects per day with dosing separated by at least 1 hour). All subsequent cohorts do not require stratification for pre-existing ADAs. After reviewing the safety data for 28 days for minimum of 8 out of 9 subjects within the cohort and all subjects have completed dosing and the inpatient monitoring until Day 4, the subjects with psoriasis will be escalated to the planned dose of GSK2831781 (1.5 and 5 mg/kg) in 6:3 ratio with placebo.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GSK2831781	Biological	GSK2831781 (100 milligram (mg)/mL) and its dilutions (Diluent - 0.9 percent saline solution containing 0.015 percent Polysorbate 80) as clear or opalescent, colourless, yellow to brown liquid solution administered by IV over approximately 2 hours.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)	Hematology parameters with PCI ranges: hematocrit (high: >0.54 percentage of red blood cells), hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8giga cells per liter [10^9/L]), neutrophil count (low: <1.510^9/L), platelet count (low: <10010^9/L and high: >55010^9/L), and while blood cell count (low: <310^9/L and high: >2010^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.	Up to 307 days
Number of Participants With Clinical Chemistry Abnormalities of PCI	Clinical chemistry parameters and their potential clinical concern values: albumin (low: <30 millimoles per liter [mmol/L]), calcium (low: <2 mmol/L, high: >2.75 mmol/L), creatinine (high: >44.2 mmol/L), glucose (low: <3 mmol/L, high: >9 mmol/L), magnesium (low: <0.5 mmol/L, high: >1.23 mmol/L), phosphorus (low: <0.8 mmol/L, high: >1.6 mmol/L), potassium (low: <3 mmol/L, high: >5.5 mmol/L), sodium (low: <130 mmol/L, high: >150 mmol/L), and total carbon dioxide (CO2) (low: <18 mmol/L, high: >32 mmol/L). Number of participants with clinical chemistry of PCI are presented.	Up to 307 days
Number of Participants With Vital Signs of PCI	Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: <40 beats per minute [BPM] and high: >110 BPM), systolic blood pressure (low: <85 and high: >160 millimeter of mercury [mmHg]), diastolic blood pressure (low: <45 mmHg and high: >100 mmHg) and body temperature (low: <35 degree Celsius and high: >37.5 degree Celsius). Number of participants with vital signs of PCI are presented.	Up to 307 days
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose	The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Part A males aged between 18 and 65 years of age and Part B males and females aged between 18 and 75 years of age inclusive, at the time of signing the informed consent
Part A: A body weight <=120 kilogram (kg) and Body mass index (BMI) within the range 19-32 kg/square meter (m^2) (inclusive), Part B: BMI within range 19-35 kg/m^2 (inclusive).
Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <=1.5x Upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent)
Based on single or averaged Electrocardiogram QT interval corrected for heart rate (QTc) values of triplicate Electrocardiogram (ECGs) obtained over a brief recording period: Electrocardiogram QT interval corrected for heart rate using Fridericia's formula (QTcF) <450 milliseconds (msec)
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

For Part A study subjects only

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the Glaxosmithkline (GSK) Medical Monitor, if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures

Delayed type hypersensitivity (DTH) cohorts only

Subjects with a history of Bacillus Calmette Guérin (BCG) vaccination as evidence by either: A BCG scar and verbal confirmation of BCG vaccination ; Or documented medical history of a BCG vaccination with or without a BCG scar
Subjects with a history of current vaccination for Tetanus, diphtheria, measles, pertussis, mumps and rubella

For Part B study subjects only

Subject has psoriasis covering Body Surface Area (BSA) >=3 percent as assessed at Screening and Day-1
Subject has had a confirmed diagnosis of chronic plaque-type psoriasis (without recent documented flare within 30 days prior to screening) for at least 6 months
Subject has at least 2 stable plaques assessed at Screening and Day -1. One of a suitable size and in a site suitable for repeat biopsy, and one for index lesion Plaque Lesional Severity Score (PLSS) scoring. Both must have a PLSS lesional score of >=2 for the induration component (moderate or above), >=1 for erythema and scaling with a total score of >=5. The biopsy lesion must not be on the face, groin or scalp and must be protected from the sun
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screening and negative urine hCG test at Day -1 for Females of Reproductive Potential [FRP]), not lactating, and at least one of the given conditions applies: Non-reproductive potential defined as pre-menopausal females with a documented tubal ligation; or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; or hysterectomy; or documented bilateral oophorectomy.

Postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

Reproductive potential and agrees to use a barrier method (male condom or female diaphragm) plus to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP from 28 days prior to the first dose of study medication and until completion of the follow-up visit.

The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. The investigator or designee should remind the subjects of the need to comply with these requirements approximately monthly, either at study visits or by telephone call until the follow-up visit.

Exclusion Criteria:

Received live vaccine (s) attenuated or recombinant within 4 weeks of Day 1 or plan to receive a live vaccination during the study until follow-up
Subjects from a high risk area of the world for tuberculosis or have history of tuberculosis or have close family members with confirmed Mycobacterium tuberculosis (MTB) infection or positive at screening by Quantiferon testing
Subject is unable to abstain from travelling to areas with high endemic rates of infectious diseases until the end of the follow up period
A medical history of severe allergic reaction, angio-edema, anaphylaxis or immunodeficiency
Subjects with neutrophil results below the normal range at screening and baseline
Subjects with any clinical, even mild, Gastrointestinal (GI) upset such as, but not limited to, diarrhea or abdominal cramping during the previous week before dosing, as well as history of more chronic GI upset, e.g. Irritable Bowel Syndrome (IBS)
Current evidence of ongoing or acute infection within 3 months prior to the first dose of study drug, such as: Serious local infection (e.g. cellulitis, abscess); Systemic infection [e.g. pneumonia, septicaemia, Tuberculosis (TB)]
Subjects who test positive for pre-existing ADA to GSK2831781 at screening.
History of malignancy, except for basal cell or squamous cell carcinoma, or in situ cervical carcinoma that has been fully treated and shows no evidence of recurrence
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8gram (g) of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits
History of sensitivity to any of the study medications or Tuberculin Purified Protein Derivative (PPD) challenge agent, or components thereof or a history of drug (or Immunoglobulin G therapeutic antibodies) or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive pre-study drug/alcohol screen
A positive test for Human Immunodeficiency Virus (HIV) antibody
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Subjects with an aspartate aminotransferase and/or gamma glutamyltransferase level above the upper limit of normal at screening and/or baseline will be excluded

For Part A study subjects only

Use of prescription drugs or non-prescription drugs, if in the opinion of the investigator (in consultation with the GSK medical monitor), the medication will interfere with the study procedures or compromise subject safety
Subjects must not currently be taking any of the following: topical steroids on the arms, oral or systemic steroids or any other immune-modulators (the washout period will be determined, on a case by case basis, by the investigator in consultation with the GSK medical monitor)
Subjects with an aspartate aminotransferase and/or gamma glutamyltransferase level above the upper limit of normal at screening and/or baseline will be excluded.

For Part A (only cohorts with DTH challenge) study subjects only:

Use of nicotine patches on the arm at screening that would interfere with the injection sites
Presence of tattoos, naevi or other skin abnormalities such as keloids (or a history of keloids) that may, in the opinion of the investigator, interfere with DTH assessments
Subjects participating, within seven days of screening, in recreational sun-bathing, or the use of a sun-bed, on the area of the skin from the wrist to the shoulder (inclusive)

For Part B study subjects only:

History of significant cardiac, endocrinologic, haematologic, pulmonary, metabolic, renal, hepatic, immunologic (excluding psoriasis and psoriatic arthritis), urologic, neurologic, dermatologic (except psoriasis), psychiatric or gastrointestinal conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at unacceptable risk
Clinically significant abnormalities of laboratory assessments (not related to disease) as judged by the investigator and/or GSK medical monitor
All systemic psoriasis medications, including psoralen long-wave ultraviolet radiation treatments, or other systemic immunosuppressives, are not allowed within 5 half lives prior to Day-1 (Methotrexate and cyclosporin are not allowed within 8 weeks of Day -1; Psoralen long-wave Ultraviolet (UV) is not allowed within 4 weeks of Day-1). Subjects should not be included if the investigator considers that the subject is at high risk of requiring rescue with prohibited medication for duration of study up to follow-up. This assessment should be based on current disease activity or a history of frequent and/or severe flares requiring systemic immunosuppression.
The use of single treatment phototherapy (ultraviolet B or self treatment with tanning beds) is not allowed within 14 days prior to Day -1
The use of topical therapies for psoriasis are not allowed with 7 days prior to Day-1 on the index lesion or biopsy plaque
Previous treatment with anti- Tumour necrosis factor (TNF)/ Interleukin (IL)-12/IL-23 or any other monoclonal antibodies is not allowed within 12 weeks prior to Day-1
Patients that require narrow therapeutic index medications from Screening to Follow-up
Vulnerable subjects (e.g. person kept in detention)
Subjects who are not able to understand and communicate in the native language of the country where the study is conducted.
Subjects who work for the Sponsor or CRO.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Bonn	North Rhine-Westphalia	53127	Germany
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
33113155	Background	Ellis J, J B Marks D, Srinivasan N, Barrett C, Hopkins TG, Richards A, Fuhr R, Albayaty M, Coenen M, Liefaard L, Leavens K, Nevin KL, Tang S, Hughes SA, Fortunato L, Edwards K, Cui Y, Anselm R, Delves CJ, Charles E, Feeney M, Webb TM, Brett SJ, Schmidt TS, Stone J, Savage COS, Wisniacki N, Tarzi RM. Depletion of LAG-3+ T Cells Translated to Pharmacology and Improvement in Psoriasis Disease Activity: A Phase I Randomized Study of mAb GSK2831781. Clin Pharmacol Ther. 2021 May;109(5):1293-1303. doi: 10.1002/cpt.2091. Epub 2020 Nov 24.

ID	Title	Description
FG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no delayed type hypersensitivity (DTH) and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
FG001	GSK2831781 0.0003 mg/kg (ADA-ve)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 24, 2017	Jan 17, 2019

Arm/Group Information

ID	Title	Description
BG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG002	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG003	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG004	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG005	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
BG006	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG007	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
BG008	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
BG009	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
BG010	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
BG011	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)

Hematology parameters with PCI ranges: hematocrit (high: >0.54 percentage of red blood cells), hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8*giga cells per liter [10^9/L]), neutrophil count (low: <1.5*10^9/L), platelet count (low: <100*10^9/L and high: >550*10^9/L), and while blood cell count (low: <3*10^9/L and high: >20*10^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.

Safety population.

Posted

Count of Participants

Participants

Up to 307 days

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG003	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG004	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG005	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG006	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG007	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG008	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG009	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG010	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG00014 OG0011 OG0021 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0010 OG0020 OG003

Primary

Number of Participants With Clinical Chemistry Abnormalities of PCI

Clinical chemistry parameters and their potential clinical concern values: albumin (low: <30 millimoles per liter [mmol/L]), calcium (low: <2 mmol/L, high: >2.75 mmol/L), creatinine (high: >44.2 mmol/L), glucose (low: <3 mmol/L, high: >9 mmol/L), magnesium (low: <0.5 mmol/L, high: >1.23 mmol/L), phosphorus (low: <0.8 mmol/L, high: >1.6 mmol/L), potassium (low: <3 mmol/L, high: >5.5 mmol/L), sodium (low: <130 mmol/L, high: >150 mmol/L), and total carbon dioxide (CO2) (low: <18 mmol/L, high: >32 mmol/L). Number of participants with clinical chemistry of PCI are presented.

Safety population.

Posted

Count of Participants

Participants

Up to 307 days

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 0.0015 mg/kg (ADA-ve)

Primary

Number of Participants With Vital Signs of PCI

Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: <40 beats per minute [BPM] and high: >110 BPM), systolic blood pressure (low: <85 and high: >160 millimeter of mercury [mmHg]), diastolic blood pressure (low: <45 mmHg and high: >100 mmHg) and body temperature (low: <35 degree Celsius and high: >37.5 degree Celsius). Number of participants with vital signs of PCI are presented.

Safety population.

Posted

Count of Participants

Participants

Up to 307 days

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 0.0015 mg/kg (ADA-ve)

Primary

Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI

Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: >450 millisecond [msec]), PR Interval (low: <110 msec and high: >220 msec) and QRS Interval (low: <75 msec and high: >110 msec). Number of participants with ECG values of PCI are presented.

Safety population.

Posted

Count of Participants

Participants

Up to 307 days

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.

Safety population.

Posted

Count of Participants

Participants

Up to 307 days

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Primary

Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha

IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Picogram per milliliter (pg/mL)

Baseline, 6, 12, 24 and 48 hours post-dose

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers

Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.

Safety population. Only those participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Day 15 and 29

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 29 and 43

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg

Safety population.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants

Primary

Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg

Safety population. Only those participants with data available at the specified time points were analyzed.

Posted

Count of Participants

Participants

6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts

Secondary

Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose

The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Millimeter (mm)

Baseline, Days 4, 8, 15 and 22 post-dose

ID	Title	Description
OG000	Placebo for Healthy Volunteer	Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.

Secondary

Duration of Induration in the Re-challenge for DTH

The duration of induration was the time (in days) to achieve an overall induration less than 6 mm from the time of the PPD re-challenge post-dose. Duration of induration was calculated as: PPD re-challenge post-dose up to the last available induration measurement. Data is presented for DTH participants.

Safety population.

Posted

Median

Full Range

Days

Up to 28 days post-dose

ID	Title	Description
OG000	Placebo for Healthy Volunteer	Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.

Secondary

Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose

A punch biopsy was taken from one of the challenge sites. Cells in biopsies of re-challenged skin were measured by immunohistochemistry (IHC) and the LAG-3+ cells characterized and counted. Baseline was considered as Day -26 for this outcome measure. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.

Safety population.

Posted

Mean

Standard Deviation

LAG3+ cells

Baseline and 72 hours post-dose

ID	Title	Description
OG000	Placebo for Healthy Volunteer	Healthy volunteers with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.

Secondary

Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29

A punch biopsy was taken from active leading edge of the lesion. Cells in lesional biopsies of skin were measured by IHC and count the LAG-3+ cells. The regions of interest for LAG3+ were located in epidermis and dermis. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

LAG3+ cells

Baseline and Day 29

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Secondary

Area Under the Plasma Time Curve From Zero to Infinity (AUC[0-infinity]) of GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma. Pharmacokinetic (PK) population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-infinity) for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-infinity) for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-infinity) for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-infinity) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Secondary

AUC(0-infinity) for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-infinity) for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-infinity) for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data was not collected because none of the participants had data evaluable for this measure.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts

Secondary

AUC(0-t) for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-t) for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve From Zero (Pre-dose) to Week 4 (AUC[0-Week 4]) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data was not collected because none of the participants had data evaluable for this measure.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24 and 696 (Week 4) hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 696 (Week 4) hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15 and 29 (Week 4) post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time point for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22 and 29 (Week 4) post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts

Secondary

AUC(0-Week 4) for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-Week 4) for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time point for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

AUC(0-Week 4) for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

h*mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

%AUCex for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

%AUCex for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

%AUCex for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

%AUCex for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Secondary

%AUCex for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

%AUCex for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

%AUCex for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Cmax for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Cmax for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Cmax for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts

Secondary

Cmax for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Cmax for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Cmax for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Geometric Mean

Geometric Coefficient of Variation

mcg/mL

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0001

Secondary

Tmax for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0001

Secondary

Tmax for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tmax for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts

Secondary

Tmax for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tmax for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tmax for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Time of Last Quantifiable Concentration (Tlast) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data was not collected because none of the participants had data evaluable for this measure.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Tlast for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0001

Secondary

Tlast for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tlast for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts

Secondary

Tlast for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tlast for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Tlast for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population.

Posted

Median

Full Range

Hours

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG0006

Secondary

Systemic Clearance of Parent Drug (CL) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

CL for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

CL for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

CL for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

CL for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units

Secondary

CL for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

CL for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

CL for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Volume of Distribution at Steady State (Vss) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Vss for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Vss for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Vss for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Vss for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units

Secondary

Vss for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Vss for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Vss for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Mean Residence Time (MRT) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

MRT for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

MRT for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

MRT for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

MRT for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units

Secondary

MRT for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

MRT for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

MRT for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Terminal Elimination Rate (Lambda z) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Lambda z for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Lambda z for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Lambda z for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Lambda z for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Secondary

Lambda z for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Lambda z for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Lambda z for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Terminal Phase Half-life (t1/2) for GSK2831781 0.0003 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

t1/2 for GSK2831781 0.0015 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

t1/2 for GSK2831781 0.0075 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

t1/2 for GSK2831781 0.04 mg/kg (ADA-ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

t1/2 for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.
OG001	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Secondary

t1/2 for GSK2831781 0.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

t1/2 for GSK2831781 1.5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

t1/2 for GSK2831781 5 mg/kg

Blood samples were collected at specified time points for GSK2831781 in plasma.

PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.

Posted

Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)

ID	Title	Description
OG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, and follow-up (Day 29)

ID	Title	Description
OG000	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 43)

ID	Title	Description
OG000	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 85)

ID	Title	Description
OG000	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 147)

ID	Title	Description
OG000	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 219)

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)

ID	Title	Description
OG000	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 237)

ID	Title	Description
OG000	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 277)

ID	Title	Description
OG000	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Positive ADAs to GSK2831781 5 mg/kg

Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.

Safety population.

Posted

Count of Participants

Participants

Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)

ID	Title	Description
OG000	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Psoriasis Area Severity Index (PASI) Scores

PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg

Secondary

Actual PASI Scores

PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score).

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Secondary

Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Number

Percentage of participants

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Secondary

Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque

PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. A negative change from Baseline is an improvement in symptoms.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG002

Secondary

Absolute PLSS Scores for the Index Plaque

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Secondary

Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants

A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Secondary

Absolute PGA Scores in Psoriasis Participants

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Mean

Standard Deviation

Scores on a scale

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Secondary

Percentage of Participants in Each PGA Score Category

A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0=clear, 1=almost clear, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.

Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Posted

Number

Percentage of participants

Baseline, Days 15, 29, 43, 85 and 121

ID	Title	Description
OG000	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.
OG001	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.
OG002	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo for Healthy Volunteer Combined	Healthy volunteers with no DTH and with DTH received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.	14	0	14	8	14
EG001	GSK2831781 0.0003 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0003 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.	1	0	1	0	1
EG002	GSK2831781 0.0015 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0015 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.	1	0	1	0	1
EG003	GSK2831781 0.0075 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.0075 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.	6	0	6	5	6
EG004	GSK2831781 0.04 mg/kg (ADA-ve)	Healthy volunteers with no DTH and without pre-existing ADA-ve status received a single dose of GSK2831781 0.04 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.	6	0	6	6	6
EG005	GSK2831781 0.15 mg/kg (ADA-ve)	Healthy volunteers received a skin challenge of 0.1 mL of 2 TU or 10 TU PPD (0.04 mcg/0.1mL), injected intradermally into the volar aspect of the left and right forearm, once in each forearm on Day 1; followed by a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 29 for 2 hours post-infusion start in healthy volunteers with DTH and with pre-existing ADA-ve status; further followed by 0.1 mL of 2 TU or 10 TU PPD was injected intradermally into the volar aspect of the left and right forearm, twice in each forearm on Day 29.	6	0	6	3	6
EG006	GSK2831781 0.15 mg/kg (ADA+ve)	Healthy volunteers with no DTH and without pre-existing ADA+ve status received a single dose of GSK2831781 0.15 mg/kg saline solution, intravenously on Day 1 for 2 hours post-infusion start.	6	0	6	3	6
EG007	Placebo for Psoriasis	Psoriasis participants received a single dose of placebo-matching saline solution, intravenously on Day 1 for 2 hours post-infusion start.	9	0	9	9	9
EG008	GSK2831781 0.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 0.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.	6	0	6	4	6
EG009	GSK2831781 1.5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 1.5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.	6	0	6	6	6
EG010	GSK2831781 5 mg/kg	Psoriasis participants with pre-existing ADA-ve and ADA+ve status received a single dose of GSK2831781 5 mg/kg saline solution, intravenously, on Day 1 for 2 hours post-infusion start.	6	1	6	6	6

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG0030 affected6 at risk EG0042 affected6 at risk EG0051 affected6 at risk EG0060 affected6 at risk EG0073 affected9 at risk EG0082 affected6 at risk EG0092 affected6 at risk EG0102 affected6 at risk
Influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Balanitis candida	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Oral herpes	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Ear infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Hordeolum	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Ophthalmic herpes zoster	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Sinusitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Lip swelling	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Sciatica	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Somnolence	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Feeling hot	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Catheter site pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Chest discomfort	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Fatigue	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Vessel puncture site bruise	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Injury associated with device	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Muscle injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Type IV hypersensitivity reaction	Immune system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Vision blurred	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Conjunctival irritation	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Erythema of eyelid	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Reticulocyte count increased	Investigations	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Dental care	Surgical and medical procedures	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003
Hypertension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected14 at risk EG0010 affected1 at risk EG0020 affected1 at risk EG003

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006967	Hypersensitivity
D007154	Immune System Diseases