Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Start Date
7/31/2025
Completion Date
1/1/2030
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 Criteria
Age Range: 18 years to 69 years
Interventions
GS-4321
GS-4321 Placebo
GS-4321
Conditions
Locations
Investigative Site
Anaheim, California 92801
United States
University of Louisville, Clinical Trials Unit
Louisville, Kentucky 40202
United States
University of Maryland, Institute of Human Virology, Clinical Research Unit
Baltimore, Maryland 21201
United States
The New York-Presbyterian Hospital
New York, New York 10021
United States
University Multi-profile Hospital for Active Treatment "SofiaMed" 00D
Sofia, 1797
Bulgaria
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia
Milan, 882
Italy
IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"
Chinsinau, 2004
Moldova
IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"
Chisinau, 2004
Moldova
PMSI Clinical Republican Hospital "Timofei Mosneaga"
Chisinau, MD-2025
Moldova
Institutul National De Boli Infectioase Prof. Dr. Matei Bals
Bucharest, 021105
Romania
Fundatia Dr. Victor Babes
Bucharest, 030303
Romania
Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals
Bucharest, 21105
Romania
Gastromedica S.R.L.
Iași, 700506
Romania
Korea University Ansan Hospital
Ansan-si, 425-707
South Korea
The Catholic University of Korea Bucheon St. Mary's Hospital
Bucheon-si, 14647
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South Korea
Samsung Medical Center
Seoul, 135-710
South Korea
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City,
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Taiwan
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan