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GS-4321

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.

Table of contents

Trial overview

The main study of GS-4321 is interventional, which means researchers give the study treatment and then measure what happens.[1] It is a Phase 1/2 trial with 107 planned participants and the status is Authorised.[1]

The trial title says it includes both healthy participants and participants with chronic hepatitis delta virus infection.[1] The study uses GS-4321 and placebo in the trial plan.[1]

Who is being studied

Part A of the study is in healthy participants, and its goal is to test single doses of GS-4321.[1] This part helps researchers learn about safety and how the body handles the study drug before it is studied in people with disease.[1]

Part B includes participants with chronic hepatitis delta infection, also called CHD.[1] In this part, the study looks at multiple doses and asks whether GS-4321 may help control the infection and improve liver test results.[1]

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.[1] 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.[1]

In Part B, one key endpoint is the proportion of participants with a combined response at Week 24.[1] 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.[1]

Part B also continues to track treatment-emergent adverse events, serious adverse events, and graded laboratory abnormalities.[1] This helps researchers see both possible benefit and safety in people with chronic hepatitis delta.[1]

Trial phase and design

This study is in Phase 1/2, so it combines early safety work with an early look at effectiveness.[1] 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.[1]

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.[1] These details help researchers compare how the drug behaves in the body by route of administration.[1]

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.[1] These checks help the study team watch for side effects and measure drug levels over time.[1]

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.[1] The study is designed to see whether the treatment can reduce HDV RNA and improve ALT while still being safe enough to continue studying.[1]

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.[1] GS-4321 is being tested first in healthy participants and then in people with the disease, which is a common step in drug development.[1]

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.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07096193 Phase 1/2 Healthy participants; chronic hepatitis delta Authorised 107

FAQ

  • Who can take part in GS-4321 clinical trials? The study includes healthy participants in one part and participants with chronic hepatitis delta in another part. Each part has different goals and different entry rules.
  • What are the trials trying to find out? The trials are checking safety, tolerability, and pharmacokinetics, which means how the body absorbs, moves, and removes GS-4321. In people with chronic hepatitis delta, the study also looks for early signs that the treatment may help.
  • What phase is the GS-4321 study? This is a Phase 1/2 trial. Phase 1 usually focuses on safety and dosing, while Phase 2 looks more closely at early effectiveness.
  • What condition is being studied? The main condition being studied is chronic hepatitis delta, also called chronic hepatitis delta virus infection. One study part also includes healthy participants.
  • What results are the researchers measuring? They are measuring treatment-emergent side effects, serious side effects, lab changes, and drug levels in the blood. In the hepatitis delta part, they also measure viral response and liver enzyme improvement at Week 24.

Ongoing Clinical Trials on GS-4321

  • Study of GS-4321 for Healthy People and Patients With Chronic Hepatitis Delta Virus Infection

    Recruiting

    2 1
    Investigated drugs:
    Bulgaria Germany Italy Romania

Glossary

  • Chronic hepatitis delta: A long-lasting liver infection caused by the hepatitis delta virus. It can make liver disease more severe.
  • Hepatitis delta virus (HDV) RNA: The genetic material of the virus. If it is undetectable, it means the test cannot find the virus in the blood.
  • Alanine aminotransferase (ALT): A liver enzyme found in blood tests. High ALT can be a sign of liver inflammation or injury.
  • Upper limit of normal (ULN): The highest value considered normal for a lab test. Results above this level may be considered abnormal.
  • Treatment-emergent adverse events (TEAEs): Health problems that start or get worse after treatment begins, whether or not they are caused by the study drug.
  • Serious adverse events (SAEs): Side effects or medical problems that are severe, life-threatening, or need hospital care.
  • Laboratory abnormalities: Blood or urine test results that are outside the normal range.
  • Pharmacokinetics (PK): The study of how the body absorbs, spreads, breaks down, and removes a drug.
  • AUC: Area under the curve. This is a measure of total drug exposure in the body over time.
  • Cmax: The highest level of a drug measured in the blood after a dose.
  • Tmax: The time it takes for a drug to reach its highest blood level.
  • t1/2: Half-life. The time it takes for the amount of a drug in the body to drop by half.

References