Study of GSK3511294 in Healthy Chinese Participants

Overview

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

Full Title of Study: “An Open-label, Single Dose Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of Two Dose Levels of GSK3511294 Administered Subcutaneously in Chinese Healthy Participants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 23, 2022

Interventions

  • Biological: GSK3511294
    • GSK3511294 will be administered.

Arms, Groups and Cohorts

  • Experimental: Cohort 1: Participants receiving GSK3511294 at Dose level 1
  • Experimental: Cohort 2: Participants receiving GSK3511294 at Dose level 2

Clinical Trial Outcome Measures

Primary Measures

  • Area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) of GSK3511294
    • Time Frame: 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
    • Time Frame: Up to Week 26
  • AUC from time 0 to Week 4 (AUC[0-Week 4]) of GSK3511294
    • Time Frame: Up to Week 4
  • AUC from time 0 to Week 12 (AUC[0-Week 12]) of GSK3511294
    • Time Frame: Up to Week 12
  • AUC from Time 0 to Week 26 [AUC(0-Week 26)] of GSK3511294
    • Time Frame: Up to Week 26
  • Percentage of AUC(0-infinity) obtained by extrapolation (%AUCex) of GSK3511294
    • Time Frame: Up to Week 26
  • Maximum observed plasma concentration (Cmax) of GSK3511294
    • Time Frame: Up to Week 26
  • Time of occurrence of Cmax (tmax) of GSK3511294
    • Time Frame: Up to Week 26
  • Time to last quantifiable concentration (tlast) of GSK3511294
    • Time Frame: Up to Week 26
  • Apparent clearance (CL/F) of GSK3511294
    • Time Frame: Up to Week 26
  • Apparent volume of distribution (Vz/F) of GSK3511294
    • Time Frame: Up to Week 26
  • Terminal elimination rate constant (lambda z) of GSK3511294
    • Time Frame: Up to Week 26
  • Terminal phase half-life (t1/2) of GSK3511294
    • Time Frame: Up to Week 26

Secondary Measures

  • Number of participants with adverse events (AEs) and serious adverse events (SAEs)
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in Hemoglobin (Grams per liter)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in hematocrit (Proportion of RBC in blood)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in mean corpuscular volume (Femtoliters)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in mean Corpuscular Hemoglobin (Picograms)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in percentage of Reticulocytes (Percentage of reticulocytes)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in Sodium, potassium, calcium, Blood urea nitrogen (Millimoles per liter)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in Creatinine, total bilirubin, direct bilirubin (Micromoles per liter)
    • Time Frame: 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)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in Albumin, Total Protein (Grams per liter)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Absolute values of Complement (C) 3 and C4
    • Time Frame: Up to Week 26
  • Ratio to Baseline of C3 and C4
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in systolic and diastolic blood pressure (Millimeters of Mercury)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in body temperature (Degrees Celsius)
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Change from Baseline in pulse rate (Beats per minute)
    • Time Frame: 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])
    • Time Frame: Baseline (Pre-dose on Day 1) and up to Week 26
  • Number of participants with positive Anti-drug Antibodies (ADAs) against GSK3511294
    • Time Frame: Up to Week 26
  • Titers of ADA against GSK3511294
    • Time Frame: Up to Week 26

Participating in This Clinical Trial

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. – 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. – Capable of giving signed informed consent. Exclusion Criteria:

  • Participant is pregnant, breastfeeding, or a woman of childbearing potential – 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 – Current evidence or recent history of an infective illness – A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse – Clinically significant abnormalities – Participants with Coronavirus Disease-2019 (COVID-19) – With prior/concurrent clinical study experience.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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