NCT05330455

Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection

Four-part, Randomized, Double-blind (Parts 1, 2A, 3 and 4), Multi-center, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK3965193 Monotherapy in Healthy Participants and in Participants Living With Chronic Hepatitis B Infection; and GSK3965193 in Combination With Bepirovirsen in Participants Living With Chronic Hepatitis B Infection

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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) and will be given the option to subsequently receive treatment with open label bepirovirsen. 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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	GSK3965193	GSK3965193 will be administered
DRUG	Placebo to match GSK3965193	Placebo to match GSK3965193 will be administered
DRUG	Bepirovirsen	Bepirovirsen will be administered

Timeline

• Start date: 2022-04-14
• Primary completion: 2025-05-19
• Completion: 2026-04-03
• First posted: 2022-04-15
• Last updated: 2025-08-19

Locations

16 sites across 6 countries: Canada, France, Italy, South Korea, Thailand, United Kingdom