NCT07096193

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

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 107 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis Delta

Interventions

Type	Name	Description
DRUG	GS-4321	Administered subcutaneous (SC) or intravenously IV
DRUG	GS-4321 Placebo	Administered SC
DRUG	GS-4321	Administered SC

Timeline

• Start date: 2025-07-31
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2025-07-31
• Last updated: 2026-04-03

Locations

12 sites across 5 countries: United States, Moldova, Romania, South Korea, Taiwan

Regulatory

• FDA-regulated drug study