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ACTIVE NOT RECRUITING
NCT05330455
PHASE1/PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2022-04-14

Completion Date

2026-04-03

Last Updated

2025-08-19

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

GSK3965193

GSK3965193 will be administered

DRUG

Placebo to match GSK3965193

Placebo to match GSK3965193 will be administered

DRUG

Bepirovirsen

Bepirovirsen will be administered

Locations (16)

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Grenoble, France

GSK Investigational Site

Lyon, France

GSK Investigational Site

Nantes, France

GSK Investigational Site

Rennes, France

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Monza MB, Italy

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Pusan, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Bangkok, Thailand

GSK Investigational Site

Cambridge, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

London, United Kingdom