In short
Clinical trials are studying GS-4321 in healthy participants and in people with chronic hepatitis delta virus infection. These trials are looking at safety, tolerability, how the body handles GS-4321, and early signs of benefit in hepatitis delta. The study includes Phase 1/2 testing in both healthy volunteers and patients with chronic hepatitis delta.
Key points
- GS-4321 is being studied in a Phase 1/2 clinical trial that includes both healthy participants and people with chronic hepatitis delta. The study first checks safety, tolerability, and pharmacokinetics in healthy participants. It also looks at early safety and possible benefit in chronic hepatitis delta. Researchers are measuring side effects, lab changes, drug levels, and in the hepatitis delta part, viral response and ALT improvement at Week 24. The trial is authorised and plans to enroll 107 participants.
Trial overview
The main study of GS-4321 is interventional, which means researchers give the study treatment and then measure what happens. It is a Phase 1/2 trial with 107 planned participants and the status is Authorised.
The trial title says it includes both healthy participants and participants with chronic hepatitis delta virus infection. The study uses GS-4321 and placebo in the trial plan.
Who is being studied
Part A of the study is in healthy participants, and its goal is to test single doses of GS-4321. This part helps researchers learn about safety and how the body handles the study drug before it is studied in people with disease.
Part B includes participants with chronic hepatitis delta infection, also called CHD. In this part, the study looks at multiple doses and asks whether GS-4321 may help control the infection and improve liver test results.
What the study measures
In Part A, the main safety measures are treatment-emergent adverse events (health problems that start after treatment begins), serious adverse events, and graded laboratory abnormalities. The study also measures pharmacokinetics, or how the body absorbs and clears GS-4321, using results such as AUClast, AUCinf, Cmax, Tmax, and t1/2.
In Part B, one key endpoint is the proportion of participants with a combined response at Week 24. This combined response means either undetectable hepatitis delta virus RNA or at least a 2 log10 drop in HDV RNA from baseline, along with normal ALT, which is a liver enzyme test.
Part B also continues to track treatment-emergent adverse events, serious adverse events, and graded laboratory abnormalities. This helps researchers see both possible benefit and safety in people with chronic hepatitis delta.
Trial phase and design
This study is in Phase 1/2, so it combines early safety work with an early look at effectiveness. Phase 1 work is done in healthy participants with single ascending doses, meaning the dose is increased step by step to learn more about safety.
The study also includes different ways of giving GS-4321 in Part A, including subcutaneous injection under the skin and intravenous infusion into a vein. These details help researchers compare how the drug behaves in the body by route of administration.
What participants may expect
People in the healthy participant part may receive a single dose of GS-4321 and have blood tests and safety checks afterward. These checks help the study team watch for side effects and measure drug levels over time.
People in the chronic hepatitis delta part may receive repeated doses and be followed for changes in virus levels and liver tests through Week 24. The study is designed to see whether the treatment can reduce HDV RNA and improve ALT while still being safe enough to continue studying.
Why these trials matter
Chronic hepatitis delta is a serious liver infection, so early clinical trials are important for finding out whether a new study treatment may be useful. GS-4321 is being tested first in healthy participants and then in people with the disease, which is a common step in drug development.
Because the study measures both safety and early signs of viral response, it may help show whether GS-4321 should be studied further in larger trials.