drugset / Trial / NCT07096193

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

NCT07096193 ↗

Phase 1/2 Recruiting 200 enrolled Gilead Sciences
Non-randomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2025-07-31
Primary completion
2030-01
Completion
2030-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GS-4321 Unknown — Subcutaneous