Study of GSK3965193 in Healthy Participants and Alone and in Combination With Bepirovirsen in Participants Living With Chronic Hepatitis B Infection - Trial NCT05330455
Access comprehensive clinical trial information for NCT05330455 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by GlaxoSmithKline and is currently Recruiting. The study focuses on Hepatitis B. Target enrollment is 132 participants.
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Study Focus
Sponsor & Location
GlaxoSmithKline
Timeline & Enrollment
Phase 1/2
Apr 14, 2022
Jan 01, 2026
Primary Outcome
Parts 1 and 2B: Number of participants with adverse events (AEs), serious adverse events (SAEs), and withdrawals due to AEs,Part 2A: Number of participants with AEs, SAEs, and withdrawals due to AEs,Parts 1 and 2B: Number of participants with clinically significant changes in laboratory parameters,Parts 1 and 2B: Number of participants with clinically significant changes in vital signs and cardiac parameters (electrocardiogram [ECG]),Part 2A: Number of participants with clinically significant changes in laboratory parameters, vital signs, cardiac parameters (ECG),Part 2A: Number of participants with clinically significant nerve changes,Part 1 and 2B: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-inf]) of GSK3965193 following single dose administration,Part 2A: AUC(0-tau) of GSK3965193 following repeat dose administration,Part 1 and 2B: maximum observed concentration (Cmax) of GSK3965193 following single dose administration,Part 2A: Cmax of GSK3965193 following repeat dose administration,Part 1 and 2B: Time to maximum observed plasma drug concentration (Tmax) of GSK3965193 following single dose administration,Part 2A: Tmax of GSK3965193 following repeat dose administration,Part 1 and 2B: Apparent terminal half-life (T1/2) of GSK3965193 following single dose administration,Part 2A: T1/2 of GSK3965193 following repeat dose administration,Part 3: Number of participants with AEs, SAEs, and withdrawals due to AEs,Part 4: Number of participants with AEs, SAEs, and withdrawals due to AEs,Part 3: Number of participants with clinically significant changes in laboratory parameters and vital signs,Part 3: Number of participants with clinically significant changes in cardiac parameters (ECG),Part 4: Number of participants with clinically significant changes in laboratory parameters and vital signs,Part 4: Number of participants with clinically significant changes in cardiac parameters (ECG),Part 3: Number of participants with clinically significant nerve changes,Part 4: Number of participants with clinically significant nerve changes,Part 3: Change from Baseline in HBsAg levels,Part 4 : Number of participants achieving sustained virologic response
Summary
This Phase 1/2a multiple part study is a first-time-in-human (FTIH) study designed to
 evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat
 doses (Part 2) of GSK3965193 in healthy participants. Part 3 will evaluate the ability of
 GSK3965193 to lower hepatitis B virus surface antigen (HBsAg) in participants living with
 chronic hepatitis B infection (PLWCHB). Part 4 will evaluate the safety and tolerability of
 combination therapy with GSK3965193 and bepirovirsen and the potential to effect sustained
 virologic response in PLWCHB.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05330455
Non-Device Trial