Study of GSK3965193 in Healthy Participants and Alone and in Combination With Bepirovirsen in Participants Living With Chronic Hepatitis B Infection
- Disease/Condition
- Hepatitis B
- Drug/Device/Intervention
- GSK3965193
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- GlaxoSmithKline
- Location
- Cambridge, United Kingdom
- Phase
- Phase 1/2
- Start date
- Apr 14, 2022
- End date
- Jan 01, 2026
- Enrollment
- 132 participants
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
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT05330455
- Type
- Non-Device Trial
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.