RecruitingPhase 1Phase 2NCT07096193

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

Sponsor

Gilead Sciences

Enrollment

200 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Hepatitis Delta

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.

Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GS-4321, a drug called GS-4321, and others for people with chronic hepatitis delta. The study is currently recruiting participants at 19 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGS-4321

Administered subcutaneous (SC) or intravenously IV

DRUGGS-4321 Placebo

Administered SC

DRUGGS-4321

Administered SC

Locations(22)

Investigative Site

Anaheim, California, United States

University of Louisville, Clinical Trials Unit

Louisville, Kentucky, 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

University Multi-profile Hospital for Active Treatment "SofiaMed" 00D

Sofia, Bulgaria

Medizinische Hochschule Hannover

Hanover, Germany

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia

Milan, Italy

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chinsinau, Moldova

IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"

Chisinau, Moldova

PMSI Clinical Republican Hospital "Timofei Mosneaga"

Chisinau, Moldova

Institutul National De Boli Infectioase Prof. Dr. Matei Bals

Bucharest, Romania

Fundatia Dr. Victor Babes

Bucharest, Romania

Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals

Bucharest, Romania

Gastromedica S.R.L.

Iași, 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

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07096193