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RECRUITING
NCT07096193
PHASE1/PHASE2

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

Sponsor: Gilead Sciences

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2025-07-31

Completion Date

2029-02

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DRUG

GS-4321

Administered subcutaneous (SC) or intravenously IV

DRUG

GS-4321 Placebo

Administered SC

DRUG

GS-4321

Administered SC

Locations (12)

Investigative Site

Anaheim, California, United States

University of Maryland, Institute of Human Virology, Clinical Research Unit

Baltimore, Maryland, United States

The New York-Presbyterian Hospital

New York, New York, United States

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chinsinau, Moldova

PMSI Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, Moldova

Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals

Bucharest, Romania

Korea University Ansan Hospital

Ansan-si, South Korea

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan