Study of GSK3511294 in Healthy Chinese Participants
Study Details
Study Description
Brief Summary
This single dose pharmacokinetic (PK) study aims to investigate the PK, safety, tolerability and immunogenicity of two dose levels of GSK3511294 administered subcutaneously in Chinese healthy participants
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: Participants receiving GSK3511294 at Dose level 1
|
Biological: GSK3511294
GSK3511294 will be administered.
|
| Experimental: Cohort 2: Participants receiving GSK3511294 at Dose level 2
|
Biological: GSK3511294
GSK3511294 will be administered.
|
Outcome Measures
Primary Outcome Measures
- Area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of GSK3511294 [Up to Week 26]
- AUC from time 0 (pre-dose) to last time of quantifiable concentration within a participant across all treatments (AUC[0-t]) of GSK3511294 [Up to Week 26]
- AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294 [Up to Week 4]
- AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294 [Up to Week 12]
- AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294 [Up to Week 26]
- Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294 [Up to Week 26]
- Maximum observed plasma concentration (Cmax) of GSK3511294 [Up to Week 26]
- Time of occurrence of Cmax (tmax) of GSK3511294 [Up to Week 26]
- Time to last quantifiable concentration (tlast) of GSK3511294 [Up to Week 26]
- Apparent clearance (CL/F) of GSK3511294 [Up to Week 26]
- Apparent volume of distribution (Vz/F) of GSK3511294 [Up to Week 26]
- Terminal elimination rate constant (lambda z) of GSK3511294 [Up to Week 26]
- Terminal phase half-life (t1/2) of GSK3511294 [Up to Week 26]
Secondary Outcome Measures
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [Up to Week 30]
- Change from Baseline in platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes and neutrophils (10^9 cells per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in Red blood cell (RBC) count (10^12 cells per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in Hemoglobin (Grams per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in hematocrit (Proportion of RBC in blood) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in mean corpuscular volume (Femtoliters) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in mean Corpuscular Hemoglobin (Picograms) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in percentage of Reticulocytes (Percentage of reticulocytes) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in Sodium, potassium, calcium, Blood urea nitrogen (Millimoles per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in Creatinine, total bilirubin, direct bilirubin (Micromoles per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) (International units per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in Albumin, Total Protein (Grams per liter) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Absolute values of Complement (C) 3 and C4 [Up to Week 26]
- Ratio to Baseline of C3 and C4 [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in systolic and diastolic blood pressure (Millimeters of Mercury) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in body temperature (Degrees Celsius) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in pulse rate (Beats per minute) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Change from Baseline in PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Fridericia's Formula (QTcF) (Milliseconds [msec]) [Baseline (Pre-dose on Day 1) and up to Week 26]
- Number of participants with positive Anti-drug Antibodies (ADAs) against GSK3511294 [Up to Week 26]
- Titers of ADA against GSK3511294 [Up to Week 26]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant between 18 to 45 years of age.
-
Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, electrocardiograms and vital signs.
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Body weight greater than or equal to (>=)50.0 kilograms (kg) for males, >=45.0 kg for females, and body mass index (BMI) within the range (19.0-26.0) kg/meter square (m^2) (inclusive).
-
Contraceptive use by men and/or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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Capable of giving signed informed consent.
Exclusion Criteria:
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Participant is pregnant, breastfeeding, or a woman of childbearing potential
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History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
-
Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe allergic reactions/intolerance
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Current evidence or recent history of an infective illness
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A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
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Clinically significant abnormalities
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Participants with Coronavirus Disease-2019 (COVID-19)
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With prior/concurrent clinical study experience.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 208021