drugset / Trial / NCT07096193
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GS-4321 | Unknown | — | Subcutaneous |