Phase 1/2 Study of GSK3965193 in HV and alone and in combination with Bepirovirsen in PLWCHB
Research type
Research Study
Full 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
IRAS ID
1004864
Contact name
Anthony Murray
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-005117-13
Clinicaltrials.gov Identifier
Research summary
Hepatitis B is an infectious disease affecting the liver caused by a virus, hepatitis B virus (HBV). This virus is spread through blood and bodily fluids. Many people with hepatitis B will not experience any symptoms and may fight off the virus without realising they had it; others may develop symptoms that last for weeks to months and then get better. However, some people are unable to clear the virus from their body and develop what is known as chronic Hepatitis B infection (CHB). CHB puts people at higher risk of suffering from liver damage (cirrhosis) and liver cancer over their lifetime.
GlaxoSmithKline (GSK) is developing a new drug (GSK3965193) for the treatment of CHB. This is the first time that GSK3965193 will be given to humans. So far it has only been tested on animals and in the laboratory. In animal studies, GSK3965193 has been shown to reduce levels of a component of Hepatitis B virus called Hepatitis B surface antigen (HBsAg). Reduction of this component is critical for curing CHB.
Healthy male and healthy female (only women who are unable to have children) participants, aged between 18 and 55 years, will be invited to participate in Part 1 or Part 2 of this study. Participants will be asked to come to GSK’s Clinical Unit Cambridge (CUC) for a short inpatient stay, followed by a number of outpatient visits.
Participants will receive single ascending or multiple oral doses of GSK3965193. Participants will be observed for any important side effects and will be assessed to determine the safety of the drug, and how the body handles the drug.
Taking part in the study will have no direct benefit to participants, but they will be helping GSK to develop a new drug for CHB for which there is currently an unmet medical need for curing the disease.REC name
Wales REC 1
REC reference
22/WA/0060
Date of REC Opinion
31 Mar 2022
REC opinion
Further Information Favourable Opinion