Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

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

This research is looking at a new medicine called GSK3965193 for people living with long-term (chronic) hepatitis B. It's a phase 1 and 2 study, meaning it's one of the first times this medicine is being given to people. The main goals are to check if it's safe, how well people tolerate it, and how it moves through the body. We'll also see if it can reduce the amount of hepatitis B virus in the blood, both on its own and when given with another medicine called bepirovirsen. Some volunteers will receive a dummy medicine (placebo) to fairly compare the results. We're hoping to find new ways to help people living with chronic hepatitis B.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

20 Aug 2024

Hepatitis B

What is this study about?

This study is about exploring a new potential treatment, known as GSK3965193, for people who have chronic hepatitis B. Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus. The study is divided into different parts, and it's what we call a 'first-in-human' study, which means it’s among the earliest stages of testing this medicine in people.

The main aims are to understand if GSK3965193 is safe and how well people tolerate it. We'll also be looking at how the body handles the medicine and how it affects the virus. In some parts of the study, GSK3965193 will be given by itself. In other parts, it will be tested alongside another existing medicine called bepirovirsen, to see if combining them might be even more effective at lowering or clearing the hepatitis B virus from the body.

Ultimately, researchers hope this study will provide important information about GSK3965193. This information could potentially lead to new and better treatment options for people living with chronic hepatitis B in the future.

Key takeaways

This study is testing a new medicine, GSK3965193, for chronic hepatitis B.
It aims to check the medicine's safety, how it's handled by the body, and its effectiveness.
The study involves healthy volunteers and people with chronic hepatitis B.
Some participants will receive a dummy medicine (placebo) or another existing drug, bepirovirsen.
Participants will have regular health checks, blood tests, and heart monitoring.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part.

Some parts of the study are for healthy volunteers, while other parts are specifically for people who have been diagnosed with chronic (long-term) hepatitis B.

The researchers will have specific health checks and medical history questions to ensure the study is safe for you and that you fit the requirements for the study. For example, they might look at your liver function or other aspects of your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have chronic (long-term) hepatitis B, or are you a healthy volunteer?
Are you able to attend regular clinic visits and appointments?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement would include several visits to a clinic or hospital for various check-ups. You would receive the study medication, which could be GSK3965193, bepirovirsen, a combination of both, or a dummy medicine (placebo) designed to look exactly like GSK3965193 tablets.

Throughout the study, doctors and nurses will closely monitor your health. This involves regular blood and urine tests to check your overall health and how the medicine is affecting your body. They'll also take measurements like your blood pressure and heart rate (using an ECG), and might check your nerve function. The length of time you'd be taking the medication and followed up afterwards varies depending on which part of the study you're in, but it could involve several weeks of treatment followed by a period of observation.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as contributing to scientific understanding and potentially receiving new treatments before they are widely available. However, there are also potential risks involved, including side effects from the study medication, which may be unknown or severe. You will be closely monitored for any health changes. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France
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Unverified
Italy

Common questions

What is chronic hepatitis B?

Chronic hepatitis B is a long-lasting infection of the liver caused by the hepatitis B virus.

What is a placebo?

A placebo is a dummy medicine that looks just like the real drug but contains no active ingredients. It helps researchers compare effects fairly.

What does 'Phase 1 and 2' mean?

These are early stages of testing a new medicine in people, focusing on safety and whether it works, before wider testing.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is getting which treatment until after the study ends.

What if I experience side effects?

Your health will be closely watched, and you should tell the study team immediately about any new or worsening symptoms. They will provide care and guidance.