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Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Sponsor: Gilead Sciences
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 - 69 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-07-31
Completion Date
2030-01
Last Updated
2026-08-27
Healthy Volunteers
Yes
Conditions
Interventions
GS-4321
Administered subcutaneous (SC) or intravenously IV
GS-4321 Placebo
Administered SC
GS-4321
Administered SC
Locations (28)
Investigative Site
Anaheim, California, United States
University of California, San Diego - Altman Clinical and Translational Research Institute
La Jolla, 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, Address: Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
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
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
Hacettepe University Faculty of Medicine Hospital Hacettepe Neighborhood
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital Oncology Hospital Universiteler Neighborhood
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital Universiteler Neighborhood, 1604th Street No: 9,
Ankara, Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakrir, Turkey (Türkiye)
Istabul University-Cerrahpasa Faculty of Medicine Hospital
Istanbul, Turkey (Türkiye)
Koc University Medical Faculty Hospital
Istanbul, Turkey (Türkiye)