First Time in Human (FTIH) Study to Evaluate Safety, Tole... | NCT03287310

ID	Type	Description	Link
2016-004256-30	EudraCT Number

Label	Type	Description	Intervention Names
Subjects receiving GSK3511294 in Cohort 1	Experimental	Six subjects in Cohort 1 will receive a single SC dose of 2 mg GSK3511294.	Drug: GSK3511294 Drug: Salbutamol/albuterol
Subjects receiving placebo in Cohort 1	Placebo Comparator	Two subjects in Cohort 1 will receive a single SC dose of placebo.	Drug: Placebo Drug: Salbutamol/albuterol
Subjects receiving GSK3511294 in Cohort 2	Experimental	Six subjects in Cohort 2 will receive a single SC dose of 10 mg GSK3511294.	Drug: GSK3511294 Drug: Salbutamol/albuterol
Subjects receiving placebo in Cohort 2	Placebo Comparator	Two subjects in Cohort 2 will receive a single SC dose of placebo.	Drug: Placebo Drug: Salbutamol/albuterol
Subjects receiving GSK3511294 in Cohort 3	Experimental	Nine subjects in Cohort 3 will receive a single SC dose of 30 mg GSK3511294.	Drug: GSK3511294 Drug: Salbutamol/albuterol

Name	Type	Description	Arm Group Labels	Other Names
GSK3511294	Drug	GSK3511294 will be available as a clear or opalescent, colorless or yellow to brown solution for injection at unit dose strength of 150 milligrams per milliliter (mg/mL). GSK3511294 will be diluted in 0.9% weight by volume (w/v) sodium chloride to achieve the desired concentration for administration. GSK3511294 will be administered by SC injection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious AEs (SAE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An 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 persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.	Up to Week 40
Number of Participants With Adverse Events of Special Interest (AESI)	AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.	Up to Week 40
Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count	Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.	Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40
Change From Baseline in Red Blood Cell Count (RBC)	Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.	Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

Secondary Outcomes

Measure	Description	Time Frame
Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg	Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis. Pharmacokinetic Population included participants in the Safety population for whom a pharmcokinetic sample was obtained and analyzed.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects should be between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Blood eosinophils of >= 200 cells/µL at screening.
A physician diagnosis of asthma (mild or moderate, as defined by the Global Initiative for Asthma [GINA], 2017) at least 12 months prior to the start of the study. The reason for diagnosis of asthma should be documented in the subject's source data, including relevant history and investigations - specifically evidence of airway hyper-responsiveness, airflow variation (peak flow rate or forced expiratory volume in one second [FEV1]) or reversible airflow obstruction should also be documented in the subject's source data.
A screening pre-bronchodilator FEV1 >= 60% of predicted normal value.
Asthma Control Test score > 19.
hsCRP of < 10 milligrams per liter (mg/L) at screening.
Otherwise healthy (other than the acceptable conditions of asthma and other atopic diseases, including allergic rhinitis and atopic dermatitis) based on a screening medical history, physical examination, vital signs, ECG assessment, pulmonary function testing, and clinical laboratory results.
Maintained controlled on as needed SABA and one of the following: a) stable dose of ICS; b) stable dose of combination therapy: ICS/LABA.
Body weight >= 50 kilograms (kg), and body mass index (BMI) of 19-32 kilograms per square meter (kg/m^2) inclusive.
Male and female subjects. a) a female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential. b) as GSK3511294 is a monoclonal antibody that is not anticipated to interact directly with Deoxyribonucleic acid (DNA) or other chromosomal material with minimal exposure through semen expected, male subjects will not be required to use contraception during the study, nor are they prohibited from donating sperm.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.

Exclusion Criteria:

Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of screening, or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening.
A history of life-threatening asthma defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
Significant pulmonary diseases, other than asthma, including (but not limited to): pneumonia previously requiring hospital admission, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other significant respiratory abnormalities.
Suspected or confirmed bacterial or viral infection (including tuberculosis) of the upper or lower respiratory tract, sinus or middle ear that occurred within and/or has not resolved within 4 weeks of screening that: led to a change in asthma management or in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study.
Positive for hepatitis B surface antigen (HBsAg) at screening.
Positive hepatitis C antibody test result at screening, or within 3 months prior to first dose of study treatment.
Known immunodeficiency (other than that explained by the use of corticosteroids), including a positive test for human immunodeficiency virus (HIV) antibody at screening.
Latent or chronic infections (example, genital herpes, urinary tract infections) or at risk of infection (example, significant trauma or infection within the 90 days before screening).
Opportunistic infection within 6 months prior to screening (example, a non-tuberculous mycobacterial infection or cytomegalovirus, pneumocystosis, aspergillosis).
Parasitic infestation within 6 months prior to screening, or have travelled to a country with a high prevalence of such infections in the 6 months before screening, or intend to do so in the year after dosing.
Live vaccine within 4 weeks prior to screening, or intention to receive live vaccine during the study.
Corrected QT by Fridericia's formula (QTcF) interval > 450 milliseconds (msec)
A personal history of severe hypertension, arrhythmia, Right Bundle Branch Block, or Left Bundle Branch Block, or a family history of sudden unexplained death, long QT, familial cardiac syndrome, or cardiomyopathy.
ALT >1.5 times upper limit of normal (ULN).
Bilirubin >1.5 times ULN. Isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Any history or presence of clinically relevant cardiac or cardiovascular, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease or immunodeficiency, or signs of acute illness, or any other illness or condition that, in the opinion of the investigator (in consultation with the medical monitor), would adversely affect the subject's participation in this study.
A previous history of cancer in remission for less than 5 years prior to screening (except for localized carcinoma of the skin that had been resected for cure) or current malignancy.
A positive drug/alcohol test before dosing, OR any history of drug abuse OR regular alcohol consumption within 6 months of the study defined as: An average weekly intake of > 14 units alcohol. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (equivalent to 240 milliliters [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Current smokers or ex-smokers who have given up smoking for < 12 months and/or have a smoking pack history of > 5 pack years (1 pack year = 20 cigarettes per day for 1 year or 5 cigarettes per day for 4 years).
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
Anticipated non-availability and/or risk of non-compliance with study visits and procedures, or unwillingness or inability to follow the study specific procedures.
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 4 investigational medicinal products within 12 months prior to the first dosing day.
History of sensitivity to any of the study medications, or its components, or a history of drug reaction or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Major surgery within 90 days prior to screening, or planned in-patient surgery or hospitalization during the study period
Donation or loss of blood or blood products in excess of 500 mL within the 3 months before dosing.
History of renal disease, abnormal kidney function or evidence of persisting or clinically relevant protein or blood on urinalysis.
History or signs of immunologically active disease (including the presence of low C3 or low C4) or thrombocytopenia.
History of vasculitis.
Subjects are excluded if they are undergoing desensitization therapy, or have received any of the following medications as indicated prior to screening: anti- Immunoglobulin E (IgE) therapy (within 6 months); anti-IL5 (within 6 months); oral or injectable corticosteroids (within 8 weeks); long acting muscarinic antagonist (LAMA) or leukotriene receptor antagonist (LTRA) therapy (within 8 weeks); drugs that can prolong the QT interval.
Subjects who are employees of the sponsor or clinical unit are excluded.
Vulnerable subjects, e.g., participants kept in detention, protected adults under guardianship, trusteeship and soldiers, or participants committed to an institution by governmental or juridical order.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Hanover	Lower Saxony	30625	Germany
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
34292606	Derived	Singh D, Fuhr R, Bird NP, Mole S, Hardes K, Man YL, Cahn A, Yancey SW, Pouliquen IJ. A Phase 1 study of the long-acting anti-IL-5 monoclonal antibody GSK3511294 in patients with asthma. Br J Clin Pharmacol. 2022 Feb;88(2):702-712. doi: 10.1111/bcp.15002. Epub 2021 Aug 24.

ID	Title	Description
FG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
FG001	GSK3511294 2 mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	May 23, 2019	Jan 25, 2021

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 Adverse Events (AEs) and Serious AEs (SAE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An 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 persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function.

Safety Population comprised of all randomized participants who received at least one dose of the study treatment.

Posted

Count of Participants

Participants

Up to Week 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG004	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
OG005	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG00012 OG0016 OG0026 OG003

Title

Denominators

Categories

Any AE

Title	Measurements
	OG00011 OG0012 OG0026 OG003

Primary

Number of Participants With Adverse Events of Special Interest (AESI)

AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling.

Safety Population.

Posted

Count of Participants

Participants

Up to Week 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG004	GSK3511294 100mg

Primary

Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count

Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Giga cells per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Primary

Change From Baseline in Red Blood Cell Count (RBC)

Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Trillion cells per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Mean Corpuscle Volume (MCV)

Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Femtoliters

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Mean Corpuscle Hemoglobin (MCH)

Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Picograms

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Hemoglobin

Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Grams per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Hematocrit

Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Proportion of red blood cells in blood

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP)

Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Milligrams per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin

Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Grams per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Clinical Chemistry Parameters Like Total Bilirubin, Direct Bilirubin and Creatinine

Blood samples were collected at indicated time-points for analysis of clinical parameters like total bilirubin, direct bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Micromoles per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003

Primary

Urine Specific Gravity Analysis by Dipstick Method

Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Ratio

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

SBP and DBP were assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Millimeters of mercury

Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Temperature

Temperature was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Degree Celsius

Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Heart Rate

Heart rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Beats per minute

Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Respiration Rate

Respiration rate was assessed in a supine position after 5 minutes of rest. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Breaths per minute

Baseline and at 2 and 8 hours at Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg

Primary

Change From Baseline in Heart Rate: Electrocardiogram (ECG)

12-lead ECG were performed in a supine position using an automated ECG machine that calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Beats per minute

Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Primary

Change From Baseline in PR Interval, QRS Interval, QT Interval and QT Interval Corrected by Fridericia's Formula (QTcF) Interval

12-lead ECG were performed in a supine position using an automated ECG machine that calculated PR interval, QRS interval, QT interval and QTcF interval. ECG measurements were performed in triplicate. When multiple ECGs were performed at the same planned timepoint, the average value of each parameter was used. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Milliseconds

Baseline and at 2 and 8 hours on Day 1; Days 2, 3, 4 and 5; Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Secondary

Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis. Pharmacokinetic Population included participants in the Safety population for whom a pharmcokinetic sample was obtained and analyzed.

Pharmacokinetic Population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

AUC(0-inf) of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Pharmacokinetic Population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

AUC(0-inf) of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Pharmacokinetic Population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Pharmacokinetic Population.

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

AUC(0-t) of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

AUC(0-t) of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Area Under the Concentration-time Curve From Time Zero to Week 4 (AUC[0-Week 4]) of GSK3511294

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 4). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, and 4 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG002	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG003	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Secondary

Area Under the Concentration-time Curve From Time Zero to Week 12 (AUC[0-Week 12]) of GSK3511294

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 12). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8 and 12 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG002	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG003	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Secondary

Area Under the Concentration-time Curve From Time Zero to Week 26 (AUC [0-Week 26]) of GSK3511294

Blood samples were collected from participants at indicated time points and analyzed for AUC (0-Week 26). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day*microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24 and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG002	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG003	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Secondary

Percentage of AUC (0-inf) Obtained by Extrapolation (%AUCex) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Percentage of AUCex

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

%AUCex of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Percentage of AUCex

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

%AUCex of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for %AUCex. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Percentage of AUCex

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Maximum Observed Concentration (Cmax) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Cmax of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Cmax of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Cmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Microgram per milliliter

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Time of Occurrence of Cmax (Tmax) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Median

Full Range

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Tmax of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Median

Full Range

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Tmax of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Tmax. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Median

Full Range

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG0006

Secondary

Time of Last Quantifiable Concentration (Tlast) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Median

Full Range

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Tlast of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population.

Posted

Median

Full Range

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Tlast of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for Tlast. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Median

Full Range

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG0006

Secondary

Apparent Clearance Following Subcutaneous Dosing (CL/F) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for CL/F. CL/F was calculated as dose divided by AUC(0-inf). Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per day

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

CL/F of GSK3511294 30 mg and 100 mg

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per day

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

CL/F of GSK3511294 300 mg

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters per day

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Apparent Volume of Distribution After Subcutaneous Administration (Vd/F) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by terminal elimination rate constant (lambda_z) *AUC(0-inf). Pharmacokinetic parameters were calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Vd/F of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for Vd/F. Vd/F was calculated as dose divided by [lambda_z *AUC(0-inf)]. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Vd/F of GSK3511294 300 mg

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Liters

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Terminal Phase Elimination Rate Constant (Lambda_z) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day^-1

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Lambda_z of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day^-1

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Lambda_z of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for lambda_z. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Day^-1

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Terminal Phase Half-life (t1/2) of GSK3511294 2 mg and 10 mg

Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, and 26 post-dose

ID	Title	Description
OG000	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG001	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Units	Counts
Participants	OG000

Secondary

T1/2 of GSK3511294 30 mg and 100 mg

Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26 and 36 post-dose

ID	Title	Description
OG000	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
OG001	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1

Units	Counts
Participants	OG000

Secondary

T1/2 of GSK3511294 300 mg

Blood samples were collected from participants at indicated time points and analyzed for t1/2. Pharmacokinetic parameters was calculated by standard non compartmental analysis.

Pharmacokinetic Population

Posted

Geometric Mean

Geometric Coefficient of Variation

Days

Pre-dose, 2 and 8 hours on Day 1; Days 2,3,5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32 and 40 post-dose

ID	Title	Description
OG000	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1

Units	Counts
Participants	OG000

Secondary

Ratio to Baseline in Absolute Blood Eosinophil Count

Blood samples were collected at indicated time-points. Analysis was performed using a mixed model repeated measures analysis (MMRM) model on log-transformed data with fixed categorical effects of treatment, planned timepoint and treatment-by-planned timepoint interaction and fixed continuous covariates of log Baseline blood eosinophil count and log Baseline blood eosinophil count-by-planned timepoint interaction. Baseline is defined as the latest predose non-missing blood eosinophil count. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Pharmacodynamic Population included participants in the 'Safety' population for whom a post-dose pharmacodynamic (ie blood eosinophil) sample was obtained and analyzed.

Pharmacodynamic Population. Only those participants with planned assessments at that particular time point has been presented (represented by n=X in category titles)

Posted

Least Squares Mean

95% Confidence Interval

Ratio of eosinophils in blood

Baseline, Days 2, 3, 4, 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36, and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1

Secondary

Number of Participants With Anti-drug Antibody (ADA) Binding to GSK3511294

Serum samples were collected to determine the presence of anti-GSK3511294 binding antibodies using a validated bioanalytical method. Data for any time post-Baseline is reported. The results were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) and persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments or a single result at the final study assessment).

Safety Population.

Posted

Count of Participants

Participants

Up to Week 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003

Secondary

Titers of Binding ADA to GSK3511294

Safety Population. Only participants with positive results for ADA were analyzed.

Posted

Median

Full Range

Titer

Up to Week 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1

Primary

Change From Baseline in Clinical Chemistry Parameters Like Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)

Blood samples were collected at indicated time-points for analysis of clinical parameters like ALP, AST and ALT. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

International units per Liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Primary

Change From Baseline in Clinical Chemistry Parameter Like Glucose, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), and Magnesium

Blood samples were collected at indicated time-points for analysis of clinical parameters like glucose, calcium, potassium, sodium, BUN, and magnesium. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Millimoles per liter

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Primary

Number of Participants With Presence of Ketones, Glucose, Occult Blood, and Protein

Urine samples were collected to analyze presence of ketones, occult blood, glucose, and protein in urine. In this dipstick test, the level of occult blood, glucose, ketones and urine protein in urine samples were recorded as negative, trace, 1+ and 2+ indicating proportional concentrations in urine. Only categories with abnormal significant values have been presented.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Count of Participants

Participants

Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1

Primary

Urine Potential of Hydrogen (pH) Analysis by Dipstick Method

Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Mean

Standard Deviation

Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003

Primary

Absolute Values of Complement (C)3 and C4

Blood samples were collected at indicated timepoints for analysis for complement (C3 and C4). Baseline was defined as latest pre-dose assessment with a non-missing value.

Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles).

Posted

Geometric Mean

95% Confidence Interval

Grams per liter

Baseline and at Days 2, 3, 4 and 5; Weeks 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40

ID	Title	Description
OG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
OG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
OG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
OG003	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events2 affected12 at risk EG0014 events2 affected6 at risk EG0021 events1 affected6 at risk EG0033 events3 affected9 at risk EG0045 events5 affected9 at risk EG0052 events2 affected6 at risk
Rhinitis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Root canal infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected6 at risk EG0022 events1 affected6 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Lethargy	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Sciatica	Nervous system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
Back injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Splinter	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0011 events1 affected6 at risk EG0020 events0 affected6 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0022 events2 affected6 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Dental pulp disorder	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Tongue discomfort	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0011 events1 affected6 at risk EG0023 events2 affected6 at risk EG003
Allergy to animal	Immune system disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0003 events3 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Peak expiratory flow rate decreased	Investigations	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Dry eye	Eye disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Pyogenic granuloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Dental care	Surgical and medical procedures	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Haematoma	Vascular disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Medical device site reaction	General disorders	MedDRA 22.0	Systematic Assessment	EG0002 events2 affected12 at risk EG0010 events0 affected6 at risk EG0021 events1 affected6 at risk EG003
Injection site haematoma	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Chest discomfort	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Cyst	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Fatigue	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Hernia pain	General disorders	MedDRA 22.0	Systematic Assessment	EG0001 events1 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003
Injection site swelling	General disorders	MedDRA 22.0	Systematic Assessment	EG0000 events0 affected12 at risk EG0010 events0 affected6 at risk EG0020 events0 affected6 at risk EG003

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D000588	Amines
D010627	Phenethylamines
D005021	Ethylamines

ID	Title	Description
BG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1
BG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1
BG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1
BG003	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1
BG004	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1
BG005	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1
BG006	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants were administered a single subcutaneous dose of GSK3511294 matching placebo on Day 1	12	12	11	12
EG001	GSK3511294 2mg	Participants were administered a single subcutaneous dose of GSK3511294 2 milligram (mg) on Day 1	6	6	2	6
EG002	GSK3511294 10mg	Participants were administered a single subcutaneous dose of GSK3511294 10 mg on Day 1	6	6	6	6
EG003	GSK3511294 30mg	Participants were administered a single subcutaneous dose of GSK3511294 30 mg on Day 1	9	9	8	9
EG004	GSK3511294 100mg	Participants were administered a single subcutaneous dose of GSK3511294 100 mg on Day 1	9	9	9	9
EG005	GSK3511294 300mg	Participants were administered a single subcutaneous dose of GSK3511294 300 mg on Day 1	6	6	4	6