A Study to Evaluate Safety, Tolerability, Pharmacokinetic... | NCT05131971 | Trialant
NCT05131971
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Mar 26, 2025Actual
Enrollment
54Actual
Phase
Phase 1
Conditions
Multiple Sclerosis
Colitis, Ulcerative
Interventions
GSK3888130B
Placebo
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05131971
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
213960
Secondary IDs
ID
Type
Description
Link
2021-002063-22
EudraCT Number
Brief Title
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PD) of GSK3888130B in Healthy Participants
Official Title
A Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3888130B in Healthy Participants Aged 18-55 Inclusive
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Mar 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 1, 2021Actual
Primary Completion Date
Oct 12, 2023Actual
Completion Date
Oct 12, 2023Actual
First Submitted Date
Oct 27, 2021
First Submission Date that Met QC Criteria
Nov 22, 2021
First Posted Date
Nov 23, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Oct 11, 2024
Results First Submitted that Met QC Criteria
Mar 25, 2025
Results First Posted Date
Mar 26, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 25, 2025
Last Update Posted Date
Mar 26, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a first time in human study designed to assess the safety, tolerability, pharmacokinetics and PD of GSK3888130B over a range of dose levels in healthy participants.
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Sclerosis
Colitis, Ulcerative
Keywords
Anti-Drug Antibodies
Double-blind
GSK3888130B
Pharmacodynamics
Pharmacokinetics
Single Dose Escalation
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
54Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Participants receiving GSK3888130B at dose level 1
Experimental
Drug: GSK3888130B
Cohort 1: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 2: Participants receiving GSK3888130B at dose level 2
Experimental
Drug: GSK3888130B
Cohort 2: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 3: Participants receiving GSK3888130B at dose level 3
Experimental
Drug: GSK3888130B
Cohort 3: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 4: Participants receiving GSK3888130B at dose level 4
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3888130B
Drug
GSK3888130B will be administered.
Cohort 1: Participants receiving GSK3888130B at dose level 1
Cohort 2: Participants receiving GSK3888130B at dose level 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Up to 160 days
Number of Participants With Clinically Significant Changes in Hematology Results
Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.
Up to 85 days
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5*10^9 cells/Liter (L), Grade 1: <0.5 to 0.2*10^9 cells/L, Grade 2: <0.2 to 0.05*10^9 cells/L, Grade 3: Below 0.05*10^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.
Baseline (Day 1) and up to 85 days
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Secondary Outcomes
Measure
Description
Time Frame
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to 55 years of age inclusive.
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participants with a confirmed positive vaccination status for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccines administered at least 30 days prior to dosing in the study.
SARS-CoV-2 screening test negative as per local guidance.
Participants with history of current/seasonal vaccination status for influenza or who consent to receive influenza vaccine at least 30 days prior to dosing, if study dosing is during influenza season (1st October to 30th April).
Body weight greater than or equal to (>=) 50 kilograms (kg) and body mass index (BMI) within the range 19.5-32 kilograms per square meter (kg/m^2) (inclusive).
Male and/or female of non-childbearing potential
Capable of giving signed informed consent.
Exclusion Criteria:
Prior medical history of anaphylaxis.
Immunodeficiency or autoimmunity assessed by medical history.
A history of recurrent infections.
Treatment of a chronic infection within 3 months prior to the first dose of study drug.
Any acute infection (including upper respiratory tract infections and urinary tract infections) which has not fully resolved within four weeks of dosing
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
Current or chronic history of liver disease or known hepatic or biliary abnormalities.
Participants with a history of renal disease or renal abnormalities.
A clinically significant abnormality in the 12-lead ECG performed at screening.
A clinically significant abnormality in the Holter monitor performed at screening.
History of malignancy, including malignant or non-malignant skin cancer.
Participants with known SARS-CoV-2 positive contacts in the past 14 days.
Prior moderate/severe SARS-CoV-2 infection requiring oxygen supplementation or admission to hospital.
Antibiotics or antiviral therapy within 30 days of dosing.
Receipt of live vaccination within 30 days of dosing or plan to receive live vaccination during the study.
Use of prescription drugs or non-prescription drugs, including non-steroidal anti inflammatory drug (NSAIDs), within 7 days prior to dosing, if in the opinion of the Investigator (in consultation with the GlaxoSmithKline [GSK] Medical Monitor if required) the medication will interfere with the study procedures or compromise participant safety.
The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day of the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than 4 new chemical entities within 12 months prior to dosing.
A positive drug/alcohol test at screening or Day -1
The participant is at high-risk of Mycobacterium tuberculosis (MTB) infection in the opinion of the Investigator.
History of asthma, allergic rhinitis or atopic dermatitis defined by the need for intermittent or continuous therapy or any other significant allergies that, in the opinion of the investigator contraindicates their participation.
History of severe adverse reaction to local anesthetic.
Presence of keloids or history of keloids.
Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5x upper limit of normal (ULN) at screening.
History or presence of excessive bleeding or coagulation disorders that in the opinion of the Investigator poses a safety risk with regards to participation in the trial.
Presence of tattoos, naevi or other skin abnormalities on the volar forearm Fitzpatrick skin color grades V in the opinion of the investigator, interfere with study assessments
Participating, within 7 days of dosing, in recreational sun-bathing, or use of sunbed, on the area of the skin from wrist to shoulder inclusive.
Current smoker or user of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) during or within 30 days prior to study participation.
An average weekly intake of >14 units of alcohol.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Cambridge
CB2 2GG
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total 54 participants were enrolled in this study. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
FG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
FG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
FG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
FG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
FG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
FG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
FG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00015 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0069 subjects
FG0076 subjects
COMPLETED
FG00015 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Placebo arms were combined as pre-specified in reporting and analysis plan.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
BG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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 Adverse Events (SAEs)
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 any serious adverse event that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Up to 160 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
Adverse Events Module
Frequency Threshold
3
Time Frame
All-cause mortality, serious adverse events (SAEs) and common non-serious adverse events (non-SAEs) were collected up to 160 days
Description
All-cause mortality, SAEs and common non-SAEs were reported for the Safety Population which included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan. Dosing information (dosage strengths) has not been disclosed as it is considered as company confidential information (CCI). Dose levels are presented as Dose levels 1 to 7 along with directionality of the dosage within each arm/group.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
Participants will be randomized to receive either GSK3888130B or placebo in single ascending dose cohorts.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
This will be a double-blind study.
Who Masked
ParticipantInvestigator
Drug: GSK3888130B
Cohort 4: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 5: Participants receiving GSK3888130B at dose level 5
Experimental
Drug: GSK3888130B
Cohort 5: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 6: Participants receiving GSK3888130B at dose level 6
Experimental
Drug: GSK3888130B
Cohort 6: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 7: Participants receiving GSK3888130B at dose level 7
Experimental
Drug: GSK3888130B
Cohort 7: Participants receiving placebo
Placebo Comparator
Drug: Placebo
Cohort 3: Participants receiving GSK3888130B at dose level 3
Cohort 4: Participants receiving GSK3888130B at dose level 4
Cohort 5: Participants receiving GSK3888130B at dose level 5
Cohort 6: Participants receiving GSK3888130B at dose level 6
Cohort 7: Participants receiving GSK3888130B at dose level 7
Placebo
Drug
Placebo will be administered.
Cohort 1: Participants receiving placebo
Cohort 2: Participants receiving placebo
Cohort 3: Participants receiving placebo
Cohort 4: Participants receiving placebo
Cohort 5: Participants receiving placebo
Cohort 6: Participants receiving placebo
Cohort 7: Participants receiving placebo
Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: <1.5* Baseline, or increase from Baseline <26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9* Baseline, or increase from Baseline >=26 umol/L, Grade 2: 2.0 to 2.9* Baseline, Grade 3: >=3.0* Baseline, or >=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.
Baseline (Day 1) and up to 85 days
Number of Participants With Clinically Significant Changes in Clinical Chemistry Results
Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.
Up to 85 days
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Baseline (Day 1) and up to 85 days
Number of Participants With Clinically Significant Changes in Vital Sign Results
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.
Up to 85 days
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.
Baseline (Day 1), Day 15 and Day 85
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive >=LLQ' and 'Positive < LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values >=LLQ were categorized as 'Positive >=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \
Baseline (Day 1), Day 15 and Day 85
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Up to 85 days
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following subcutaneous administration.
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Tmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Tmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Half-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
t1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
t1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Clearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Clearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
CL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Baseline was defined as the latest pre-dose assessment.
Baseline (Day 1), Day 15, Day 29, Day 57 and Day 85
Percent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood
Free IL-7 levels were derived from total IL-7 and total GSK3888130B concentrations (named as Derived Free IL-7) over time using a nonlinear mixed effects modelling approach. A target-mediated drug disposition model was used to fit the total IL-7 and total GSK3888130B assay concentration data to derive the free-IL-7 concentrations. Peak reduction relative to Baseline (Percent change) was calculated for each participant as; Peak reduction = (1 - minimum [Free IL7/IL7 Baseline])*100. Baseline was defined as the latest pre-dose assessment.
Baseline (Day 1) and up to 8 hours
Median Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood
Blood samples were collected at indicated time points to measure Bcl-2 Expression in CD4+ T Cells as median fluorescence intensity (MdFI). Baseline was defined as the latest pre-dose assessment. MdFI values as a measure of Bcl-2 expression in CD4+ T cells was measured by flow cytometry. Placebo arms were combined as pre-specified in reporting and analysis plan.
Baseline (Day 1) and Day 15
6 subjects
FG0056 subjects
FG0069 subjects
FG0076 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
BG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
BG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
BG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
BG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
BG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
BG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
BG008
Total
Total of all reporting groups
15
BG0013
BG0023
BG0036
BG0046
BG0056
BG0069
BG0076
BG00854
Standard Deviation
YEARS
Title
Denominators
Categories
Title
Measurements
BG00040.3± 8.93
BG00140.0± 7.94
BG00248.3± 3.06
BG00338.8± 8.75
BG00441.2± 9.52
BG00540.8± 7.70
BG00638.7± 9.86
BG00741.5± 11.57
BG00840.6± 8.78
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Male
BG00015
BG0013
BG0023
BG0036
BG004
Race/Ethnicity, Customized
The "All Other Races" category (ASIAN, WHITE and MIXED RACE where 0\
Count of Participants
Participants
Title
Denominators
Categories
All Other Races
Title
Measurements
BG00015
BG0013
BG0023
BG0036
BG0046
BG0056
BG0069
BG0076
BG00854
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG0036
OG0046
OG0056
OG0069
OG0076
Title
Denominators
Categories
AEs
Title
Measurements
OG0008
OG0013
OG0022
OG0036
OG0042
OG0054
OG0068
OG0075
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Clinically Significant Changes in Hematology Results
Blood samples were collected for analysis of following hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin (Hg), Lymphocytes, Mean corpuscular Hg, Mean corpuscular volume, Monocytes, Platelet count, Red blood cell count, Reticulocytes, Total Neutrophils, and White blood cells count (WBC). Number of participants with clinically significant changes in hematology were reported. Clinical significance was determined by the investigator.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Worst-case Cluster of Differentiation (CD) 4+ T Cell Counts Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of CD4+ T Cell Counts. The CD4+ T Cell Counts were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE). Grade 0: Above 0.5*10^9 cells/Liter (L), Grade 1: <0.5 to 0.2*10^9 cells/L, Grade 2: <0.2 to 0.05*10^9 cells/L, Grade 3: Below 0.05*10^9 cells/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Increase to Grade 1
Title
Measurements
OG0004
OG0011
OG0021
OG003
Primary
Number of Participants With Worst-case Creatinine Results by Maximum Grade Increase Post-Baseline Relative to Baseline
Blood samples were collected for the analysis of Creatinine. Creatinine was graded according to the NCI-CTCAE. Grade 0: <1.5* Baseline, or increase from Baseline <26 micromoles per liter (umol/L), Grade 1: 1.5 to 1.9* Baseline, or increase from Baseline >=26 umol/L, Grade 2: 2.0 to 2.9* Baseline, Grade 3: >=3.0* Baseline, or >=354 umol/L. Baseline was defined as the latest pre-dose assessment. An increase was defined as an increase in grade relative to Baseline grade. Any worst-case post Baseline increase to Grade 1, Grade 2 and Grade 3 are presented.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Increase to Grade 1
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Clinically Significant Changes in Clinical Chemistry Results
Blood samples were collected for analysis of following clinical chemistry parameters: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Calcium, Total and Direct bilirubin, Glucose, Potassium, Sodium, Total protein, Lactate dehydrogenase, Haptoglobins and Urea. Number of participants with clinically significant changes in clinical chemistry were reported. Clinical significance was determined by the investigator.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Worst-case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline
Urine samples were collected for analysis of Specific gravity, potential of hydrogen (pH), glucose, protein, erythrocytes, ketones, bilirubin, urobilinogen, nitrite, and leukocyte in urine by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase means any increase to trace, 1+, 2+ or 3+ post-Baseline relative to Baseline. Baseline was defined as the latest pre-dose assessment. Number of participants with worst-case any increase in urinalysis results post-Baseline relative to Baseline has been presented.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Baseline (Day 1) and up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Bilirubin
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Clinically Significant Changes in Vital Sign Results
Vital signs included systolic and diastolic blood pressure, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring. Clinical significance was determined by the investigator.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Positive Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) and Varicella Zoster Virus (VZV) DNA
VZV-Nucleic acid from blood samples were extracted using the QIASymphony SP followed by TaqMan real time polymerase chain reaction (PCR) for amplification and detection. Murine cytomegalovirus (mCMV) was used as an internal control (IC) and was introduced during the extraction process. CMV-Nucleic acid was extracted using the QIASymphony SP/AS followed by automated set up of Artus real time PCR using the Rotor-Gene Q for amplification and detection. Baseline was defined as the latest pre-dose assessment. Number of participants with Positive CMV DNA and VZV DNA has been presented.
Safety Population included all participants who received study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Baseline (Day 1), Day 15 and Day 85
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Cytomegalovirus DNA, Baseline (Day 1)
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Primary
Number of Participants With Positive Epstein-Barr Virus (EBV) DNA
EBV DNA was assessed and qualitative data has been presented. Data has been categorized into 'Positive >=LLQ' and 'Positive < LLQ'. LLQ is lower limit of quantification. Participants who had EBV DNA values >=LLQ were categorized as 'Positive >=LLQ'. This represents a positive result that is above the assay limit of quantification. Participants who had EBV DNA values \
Safety Population included all participants who received study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Baseline (Day 1), Day 15 and Day 85
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Baseline (Day 1), Positive < LLQ
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Primary
Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT corrected interval. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with worst case post-Baseline abnormal ECG findings have been presented.
Safety Population included all participants who received study intervention. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Up to 85 days
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
CLINICALLY SIGNIFICANT
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Serum Concentrations of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
PK Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Posted
Geometric Mean
95% Confidence Interval
Nanograms per milliliter (ng/mL)
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG001
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG002
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
Units
Counts
Participants
OG0003
OG0013
OG0026
Title
Denominators
Categories
DAY 1 (Pre-dose)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
Secondary
Serum Concentrations of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following subcutaneous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG001
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
DAY 1 (Pre-dose)
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG001NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
DAY 1 (4 Hours)
Title
Measurements
Secondary
Serum Concentrations of GSK3888130B for Dose Levels 6 and 7 IV Administration
Blood samples were collected at indicated time points for measurement of serum concentrations of GSK3888130B following intravenous administration. Pharmacokinetic (PK) Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Pharmacokinetic (PK) Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points.
Posted
Geometric Mean
95% Confidence Interval
ng/mL
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG001
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG0009
OG0016
Title
Denominators
Categories
DAY 1 (Pre-dose)
ParticipantsOG0009
ParticipantsOG0016
Title
Measurements
OG000NA(NA to NA)
Secondary
Area Under the Concentration-time Curve From Time Zero to Time t (AUC[0 to t]) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*micrograms per milliliter(h*ug/mL)
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG001
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG002
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
Units
Counts
Participants
OG0003
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG00065.81± 75.50
OG0011837.01± 48.86
OG00213524.34± 16.29
Secondary
AUC(0 to t) for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG001
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0003550.71± 38.63
OG00135669.70± 25.35
Secondary
AUC(0 to t) for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
h*ug/mL
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG001
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG0009
OG0016
Title
Denominators
Categories
Title
Measurements
OG000153885.4± 12.54
OG001387454.3± 24.96
Secondary
Maximum Observed Plasma Concentration (Cmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Micrograms per milliliter (ug/mL)
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG001
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG002
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
Units
Counts
Participants
OG0003
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG0000.9034± 21.5707
OG0014.8156± 18.7069
OG00235.6330± 14.4965
Secondary
Cmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG001
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0003.4609± 31.2624
OG00136.3795± 24.9230
Secondary
Cmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
ug/mL
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG001
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG0009
OG0016
Title
Denominators
Categories
Title
Measurements
OG000386.4759± 29.7837
OG001907.7045± 11.2907
Secondary
Time to Cmax (Tmax) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Median
Full Range
Hour
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG001
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG002
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
Units
Counts
Participants
OG0003
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG0000.583(0.55 to 4.00)
OG0010.550(0.55 to 4.00)
OG0020.558(0.55 to 0.58)
Secondary
Tmax of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Median
Full Range
Hour
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG001
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG000168.000(120.00 to 222.12)
OG001143.475(120.00 to 240.95)
Secondary
Tmax of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Median
Full Range
Hour
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG001
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG0009
OG0016
Title
Denominators
Categories
Title
Measurements
OG0001.083(1.05 to 24.00)
OG0012.533(1.05 to 8.00)
Secondary
Half-life (t1/2) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG001
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG002
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
Units
Counts
Participants
OG0003
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG000123.73± 35.44
OG001633.05± 32.53
OG002627.11± 17.66
Secondary
t1/2 of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG001
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG000784.05± 13.62
OG001749.02± 31.55
Secondary
t1/2 of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Hour
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG001
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG0009
OG0016
Title
Denominators
Categories
Title
Measurements
OG000563.53± 22.12
OG001628.91± 13.71
Secondary
Clearance (CL) of GSK3888130B for Dose Levels 1, 2 and 4 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
Milliliter per hour (mL/h)
Day 1: Pre-dose, 15 minutes, 30 minutes, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG001
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG002
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
Units
Counts
Participants
OG0003
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG00021.501± 38.138
OG0014.240± 52.782
OG0026.542± 22.034
Secondary
Clearance Factor (CL/F) of GSK3888130B for Dose Levels 3 and 5 Subcutaneous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following subcutaneous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
Day 1: Pre-dose, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG001
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0009.149± 36.810
OG0019.297± 27.211
Secondary
CL of GSK3888130B for Dose Levels 6 and 7 Intravenous Administration
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3888130B following intravenous administration.
Pharmacokinetic Population consisted of all participants in the Safety analysis set who had received an active study intervention and had at least 1 non-missing post dose PK assessment (Non-quantifiable [NQ] values were considered as non-missing values).
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
Day 1: Pre-dose, 30 minutes, 1 hour, 4, 8, 12, 24, 48 hours; Days 6, 8, 10, 15, 21, 29, 57, and 85
ID
Title
Description
OG000
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG001
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG0009
OG0016
Title
Denominators
Categories
Title
Measurements
OG0005.920± 11.548
OG0016.860± 28.592
Secondary
Number of Participants With Positive Anti-drug Antibodies Against GSK3888130B
Serum samples were collected for the determination of anti-drug antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Baseline was defined as the latest pre-dose assessment.
Safety Population included all participants who received study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for the specified time points. Placebo arms were combined as pre-specified in reporting and analysis plan.
Posted
Count of Participants
Participants
Baseline (Day 1), Day 15, Day 29, Day 57 and Day 85
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
Secondary
Percent Peak Reduction From Baseline in Derived Free Interleukin 7 (IL 7) in Blood
Free IL-7 levels were derived from total IL-7 and total GSK3888130B concentrations (named as Derived Free IL-7) over time using a nonlinear mixed effects modelling approach. A target-mediated drug disposition model was used to fit the total IL-7 and total GSK3888130B assay concentration data to derive the free-IL-7 concentrations. Peak reduction relative to Baseline (Percent change) was calculated for each participant as; Peak reduction = (1 - minimum [Free IL7/IL7 Baseline])*100. Baseline was defined as the latest pre-dose assessment.
Pharmacodynamic (PD) Population consisted of all participants in the Safety Population who had at least one post Baseline PD result. Placebo arms were combined as pre-specified in reporting and analysis plan. Zeros reported reflect measured data derived during analysis.
Posted
Mean
Standard Deviation
Percent Change
Baseline (Day 1) and up to 8 hours
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.00
OG00195.8± 1.5383
OG00299.1± 0.2841
OG003
Secondary
Median Fluorescence Intensity (MdFI) of B-cell Lymphoma 2 (Bcl-2) Expression in CD4+ T Cells in Blood
Blood samples were collected at indicated time points to measure Bcl-2 Expression in CD4+ T Cells as median fluorescence intensity (MdFI). Baseline was defined as the latest pre-dose assessment. MdFI values as a measure of Bcl-2 expression in CD4+ T cells was measured by flow cytometry. Placebo arms were combined as pre-specified in reporting and analysis plan.
Pharmacodynamic (PD) Population consisted of all participants in the Safety Population who had at least one post Baseline PD result. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Median
Full Range
Median fluorescence intensity
Baseline (Day 1) and Day 15
ID
Title
Description
OG000
Placebo
Participants received a placebo matching GSK3888130B either intravenous (IV) infusion or subcutaneous (SC) injection on Day 1.
OG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
OG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
OG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
OG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
OG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
OG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
OG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
Units
Counts
Participants
OG00015
OG0013
OG0023
OG003
Title
Denominators
Categories
Baseline (Day 1)
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG003
0
15
0
15
8
15
EG001
GSK3888130B Dose Level 1 IV
Participants received a single dose of GSK3888130B dose level 1, intravenous (IV) infusion on Day 1. Dose level 1 is the lowest dose level.
0
3
0
3
3
3
EG002
GSK3888130B Dose Level 2 IV
Participants received a single dose of GSK3888130B dose level 2, IV infusion on Day 1. Dose level 2 is greater than dose level 1.
0
3
0
3
2
3
EG003
GSK3888130B Dose Level 3 SC
Participants received a single dose of GSK3888130B dose level 3, subcutaneous (SC) injection on Day 1. Dose level 3 is greater than dose level 2.
0
6
0
6
6
6
EG004
GSK3888130B Dose Level 4 IV
Participants received a single dose of GSK3888130B dose level 4, IV infusion on Day 1. Dose level 4 is greater than dose level 3.
0
6
0
6
2
6
EG005
GSK3888130B Dose Level 5 SC
Participants received a single dose of GSK3888130B dose level 5, SC injection on Day 1. Dose level 5 is greater than dose level 4.
0
6
0
6
4
6
EG006
GSK3888130B Dose Level 6 IV
Participants received a single dose of GSK3888130B dose level 6, IV infusion on Day 1. Dose level 6 is greater than dose level 5.
0
9
0
9
8
9
EG007
GSK3888130B Dose Level 7 IV
Participants received a single dose of GSK3888130B dose level 7, IV infusion on Day 1. Dose level 7 is the highest dose level.
0
6
0
6
5
6
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Ear pain
Ear and labyrinth disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
Nausea
Gastrointestinal disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Toothache
Gastrointestinal disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Catheter site pain
General disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Catheter site rash
General disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Fatigue
General disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Influenza like illness
General disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Injection site pruritus
General disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Malaise
General disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Swelling face
General disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Hypertransaminasaemia
Hepatobiliary disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events2 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Seasonal allergy
Immune system disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Acne pustular
Infections and infestations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
COVID-19
Infections and infestations
26.1
Systematic Assessment
EG0003 events3 affected15 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Cellulitis
Infections and infestations
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Infected cyst
Infections and infestations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Influenza
Infections and infestations
26.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Lower respiratory tract infection
Infections and infestations
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Nasopharyngitis
Infections and infestations
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events3 affected9 at risk
EG0070 events0 affected6 at risk
Oral herpes
Infections and infestations
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Arthropod bite
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Contusion
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
Ligament sprain
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Procedural pain
Injury, poisoning and procedural complications
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Aspartate aminotransferase increased
Investigations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Blood creatine phosphokinase increased
Investigations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Blood pressure diastolic increased
Investigations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Blood pressure increased
Investigations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
Haemoglobin decreased
Investigations
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Myalgia
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
26.1
Systematic Assessment
EG0002 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Head discomfort
Nervous system disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Headache
Nervous system disorders
26.1
Systematic Assessment
EG0003 events3 affected15 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0062 events2 affected9 at risk
EG0072 events1 affected6 at risk
Paraesthesia
Nervous system disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0071 events1 affected6 at risk
Taste disorder
Nervous system disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Cough
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected9 at risk
EG0072 events2 affected6 at risk
Skin irritation
Skin and subcutaneous tissue disorders
26.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected9 at risk
EG0070 events0 affected6 at risk
Hypotension
Vascular disorders
26.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected6 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D001327
Autoimmune Diseases
D007154
Immune System Diseases
D003092
Colitis
D005759
Gastroenteritis
D005767
Gastrointestinal Diseases
D004066
Digestive System Diseases
D015212
Inflammatory Bowel Diseases
D003108
Colonic Diseases
D007410
Intestinal Diseases
6
BG0056
BG0069
BG0076
BG00854
0
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0069
OG0076
0
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0069
OG0076
1
OG0041
OG0053
OG0065
OG0074
Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0069
OG0076
0
OG0040
OG0050
OG0061
OG0070
Increase to Grade 2
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Increase to Grade 3
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0069
OG0076
0
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0069
OG0076
0
OG0040
OG0050
OG0060
OG0070
Erythrocytes
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0052
OG0061
OG0070
Glucose
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
Ketones
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
Leukocytes
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Nitrite
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Protein
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0072
Specific Gravity
Title
Measurements
OG0008
OG0013
OG0022
OG0034
OG0045
OG0056
OG0065
OG0076
Urobilinogen
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
pH
Title
Measurements
OG00012
OG0013
OG0022
OG0035
OG0044
OG0056
OG0068
OG0075
6
OG0046
OG0056
OG0069
OG0076
0
OG0040
OG0050
OG0060
OG0070
6
OG0046
OG0056
OG0069
OG0076
6
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Cytomegalovirus DNA, Day 15
ParticipantsOG00015
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Cytomegalovirus DNA, Day 85
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Varicella Zoster Virus DNA, Baseline (Day 1)
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Varicella Zoster Virus DNA, Day 15
ParticipantsOG00015
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Varicella Zoster Virus DNA, Day 85
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
6
OG0046
OG0056
OG0069
OG0076
6
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0071
Baseline (Day 1), Positive >= LLQ
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0002
OG0010
OG0020
OG003
Day 15, Positive < LLQ
ParticipantsOG00015
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 15, Positive >= LLQ
ParticipantsOG00015
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 85, Positive < LLQ
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0000
OG0010
OG0020
OG003
Day 85, Positive >= LLQ
ParticipantsOG00015
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0076
Title
Measurements
OG0001
OG0011
OG0020
OG003
6
OG0046
OG0056
OG0069
OG0076
0
OG0040
OG0050
OG0060
OG0070
NOT CLINICALLY SIGNIFICANT
Title
Measurements
OG00012
OG0011
OG0022
OG0036
OG0044
OG0056
OG0067
OG0075
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being non-quantifiable (NQ).
OG001NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG002NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
DAY 1 (15 Minutes)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000363.2(196.7 to 670.9)
OG0012155.9(1003.0 to 4634.4)
OG00215901.1(13993.4 to 18069.0)
DAY 1 (30 Minutes)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000893.1(504.7 to 1580.5)
OG0014717.5(3173.3 to 7013.1)
OG00235633.0(30628.5 to 41455.2)
DAY 1 (4 Hours)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000761.4(677.2 to 856.1)
OG0014497.0(2542.8 to 7953.0)
OG00232762.8(28319.4 to 37903.3)
DAY 1 (8 Hours)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000753.5(483.7 to 1173.8)
OG0013964.2(1974.7 to 7958.0)
OG00231180.8(27855.3 to 34903.4)
DAY 1 (12 Hours)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000758.1(601.3 to 955.8)
OG0013599.9(2601.7 to 4981.2)
OG00229821.8(26986.2 to 32955.3)
DAY 1 (24 Hours)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000720.8(558.6 to 930.0)
OG0013781.5(2095.7 to 6823.7)
OG00228096.6(26173.0 to 30161.6)
DAY 1 (48 Hours)
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000572.8(401.3 to 817.7)
OG0013184.0(2280.6 to 4445.1)
OG00223358.3(20418.2 to 26721.8)
DAY 6
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0012134.0(1229.6 to 3703.5)
OG00215978.7(14176.6 to 18009.9)
DAY 8
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0011862.5(883.6 to 3926.1)
OG00214071.9(13088.2 to 15129.5)
DAY 10
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0011850.1(928.4 to 3687.1)
OG00212873.0(11718.1 to 14141.7)
DAY 15
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0011539.6(740.1 to 3202.8)
OG00210293.7(9018.8 to 11748.8)
DAY 21
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0025
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0011263.0(416.5 to 3829.5)
OG0028485.9(7647.8 to 9415.9)
DAY 29
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0011027.3(404.7 to 2607.4)
OG0026904.9(5741.6 to 8304.0)
DAY 57
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG001625.4(192.9 to 2027.2)
OG0023545.2(2721.4 to 4618.4)
DAY 85
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG001NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0021797.5(1152.8 to 2802.8)
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0012540.4(1193.5 to 5407.6)
DAY 1 (8 Hours)
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0015287.2(2659.9 to 10509.8)
DAY 1 (12 Hours)
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0018236.8(4122.6 to 16456.5)
DAY 1 (24 Hours)
Title
Measurements
OG0001284.2(795.2 to 2073.7)
OG00114161.9(7502.7 to 26731.7)
DAY 1 (48 Hours)
Title
Measurements
OG0002297.0(1506.7 to 3501.9)
OG00123239.0(12191.4 to 44297.5)
DAY 6
Title
Measurements
OG0003253.7(2339.4 to 4525.5)
OG00134612.8(25180.0 to 47579.2)
DAY 8
Title
Measurements
OG0003327.1(2422.0 to 4570.5)
OG00134801.7(25828.6 to 46892.0)
DAY 10
Title
Measurements
OG0003078.4(2316.4 to 4091.2)
OG00133654.8(25702.9 to 44066.9)
DAY 15
Title
Measurements
OG0002814.4(2172.0 to 3646.8)
OG00129870.9(22782.2 to 39165.2)
DAY 21
Title
Measurements
OG0002856.1(2199.3 to 3709.1)
OG00127433.3(21634.8 to 34785.7)
DAY 29
Title
Measurements
OG0002266.1(1614.4 to 3181.0)
OG00121108.5(16241.6 to 27434.0)
DAY 57
Title
Measurements
OG0001288.8(817.0 to 2032.9)
OG00111567.5(7780.8 to 17197.0)
DAY 85
Title
Measurements
OG000NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG0015780.9(3113.3 to 10733.9)
Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.
OG001NA(NA to NA)Geometric mean and 95% CI could not be calculated if any values were imputed due to being NQ.