← Back to Search

Antiviral Agent

GSK3965193 for Hepatitis B

Phase 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parts 1 and 2: Participants between 18 and 55 years of age inclusive, at the time of signing the informed consent.

Parts 3 and 4: Participants between 18 and 65 years of age inclusive, at the time of signing the informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is divided into different parts to study the safety and effectiveness of a drug called GSK3965193. The first parts will focus on how the drug is processed in the body when given as

Who is the study for?

This trial is for healthy adults aged 18-55 and those with chronic hepatitis B aged 18-65, who are not pregnant or breastfeeding and use effective contraception. Participants must weigh at least 50 kg with a BMI of 18-32 kg/m^2. For parts involving patients with hepatitis, they must have been diagnosed over six months ago and be on stable antiviral therapy.

What is being tested?

The study tests GSK3965193's safety, tolerability, and pharmacokinetics in healthy individuals (Parts 1 & 2) and its effect on lowering the hepatitis B surface antigen in infected participants (Part 3). Part 4 explores combining GSK3965193 with bepirovirsen to achieve sustained virologic response in those infected.

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions to new medications such as headaches, nausea, allergic reactions or specific issues related to liver function given the nature of the disease being targeted.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 55 years old.

Select...

I am between 18 and 65 years old.

Select...

I weigh at least 50 kg and my BMI is between 18-32.

Select...

I am on a stable dose of antiviral medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

9Treatment groups

Experimental Treatment

Group I: Part 4 Cohort 8: GSK3965193 and bepirovirsen or placebo and bepirovirsenExperimental Treatment3 Interventions

PLWCHB participants on stable NA therapy who have not participated in Part 3 of the study will be randomized 3:1 to receive repeat dose either GSK3965193 or placebo. In addition, all participants in this cohort will also receive bepirovirsen. This part will commence after completion of Part 3, contingent on the clinical safety and efficacy data from Part 3.

Group II: Part 3 Sub-Cohort 7: Open label bepirovirsenExperimental Treatment1 Intervention

PLWCHB participants on stable NA therapy who have completed GSK3965193/placebo monotherapy (Part 3, Cohort 7) will be given the option to receive subsequent treatment of optional open label bepirovirsen only for 24 weeks.

Group III: Part 3 Cohort 7: GSK3965193 or placeboExperimental Treatment2 Interventions

PLWCHB on stable nucleos(t)ide analog (NA) therapy will be randomized 3:1 to receive repeat dose of either GSK3965193 (Dose E) or placebo. This part will commence after completion of both Part 1 and Part 2.

Group IV: Part 2B Cohort 6: GSK3965193Experimental Treatment1 Intervention

Healthy Participants will be randomized 1:1 to receive single doses of GSK3965193 (Dose A) under fasted and fed conditions in treatment period 1. In period 2, the participants who received GSK3965193 (Dose A) under fasted conditions in treatment period 1 will receive the same dose under fed conditions, and vice versa. In the third period, all participants will receive a single dose of GSK3965193 (Dose B) different strength under fasted conditions. The dose level for the third period will be selected based on the results of the first two periods. There will be a minimum of 7 days washout between dosing in each treatment period.

Group V: Part 2A Cohort 5: GSK3965193 or placeboExperimental Treatment2 Interventions

Healthy participants will be randomized 3:1 to receive repeat doses of either GSK3965193 (Dose X) or placebo under fasted conditions. Part 2A may start while Part 1 is still ongoing. The starting dose in Part 2 will be at least 3-fold below the highest dose completed in Part 1.

Group VI: Part 2A Cohort 4: GSK3965193 or placeboExperimental Treatment2 Interventions

Group VII: Part 2A Cohort 3: GSK3965193 or placeboExperimental Treatment2 Interventions

Group VIII: Part 1 Cohort 2: GSK3965193 and placeboExperimental Treatment2 Interventions

Healthy participants will be randomized to receive single ascending doses of GSK3965193 and placebo in one of 4 treatment sequences in a 3:1 ratio in fasted conditions. In period 1, participants will receive GSK3965193 (Dose 5) + Placebo; in period 2: GSK3965193 (Dose 6) + Placebo; in period 3: GSK3965193 (Dose 7) + Placebo and in period 4: GSK3965193 (Dose 8) + Placebo. There will be a minimum of 7 days washout between dosing in each period.

Group IX: Part 1 Cohort 1: GSK3965193 and placeboExperimental Treatment2 Interventions

Healthy participants will be randomized to receive single ascending doses of GSK3965193 and placebo in one of 4 treatment sequences in a 3:1 ratio in fasted conditions. In period 1, participants will receive GSK3965193 (Dose 1) + Placebo; in period 2: GSK3965193 (Dose 2) + Placebo; in period 3: GSK3965193 (Dose 3) + Placebo and in period 4: GSK3965193 (Dose 4) + Placebo. There will be a minimum of 7 days washout between dosing in each treatment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bepirovirsen

2023

Completed Phase 1

~160

0 / 4Eligibility criteria met