Clinical Trial

Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD). The primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants. The primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.
Protocol Amendment History 8 changes
notable Trial sites expanded: 19 -> 22 locations 2026-07-31
critical Primary endpoint(s) modified 2026-06-12
notable Enrollment increased: 107 -> 200 participants 2026-06-12
notable Trial sites expanded: 15 -> 19 locations 2026-06-12
notable Primary completion pushed: 2029-02 -> 2030-01 2026-06-12
minor Completion pushed: 2029-02 -> 2030-01 2026-06-12
notable Trial sites expanded: 12 -> 15 locations 2026-04-30
notable Trial sites expanded: 8 -> 12 locations 2026-04-04
Trial Details
NCT Number NCT07096193
Lead Sponsor Gilead Sciences
Conditions Chronic Hepatitis Delta
Enrollment 200 participants
Start Date 2025-07-31
Primary Completion 2030-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30