Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Chronic Hepatitis Delta
In brief
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.
Key facts
- Study ID
- NCT07096193
- Run by
- Gilead Sciences
- People needed
- 200
- Starts
- 2025-07-31
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.
Where it is running
- Investigative Site — Anaheim, California, United States (enrolling)
- University of Louisville, Clinical Trials Unit — Louisville, Kentucky, United States (enrolling)
- University of Maryland, Institute of Human Virology, Clinical Research Unit — Baltimore, Maryland, United States (enrolling)
- The New York-Presbyterian Hospital — New York, New York, United States (enrolling)
- University Multi-profile Hospital for Active Treatment "SofiaMed" 00D — Sofia, Bulgaria (enrolling)
- Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia — Milan, Italy (enrolling)
- IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" — Chinsinau, Moldova (enrolling)
- IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" — Chisinau, Moldova (enrolling)
- PMSI Clinical Republican Hospital "Timofei Mosneaga" — Chisinau, Moldova (enrolling)
- Institutul National De Boli Infectioase Prof. Dr. Matei Bals — Bucharest, Romania (enrolling)
- Fundatia Dr. Victor Babes — Bucharest, Romania (enrolling)
- Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals — Bucharest, Romania (enrolling)
- Gastromedica S.R.L. — Iași, Romania (enrolling)
- Korea University Ansan Hospital — Ansan-si, South Korea (enrolling)
- The Catholic University of Korea Bucheon St. Mary's Hospital — Bucheon-si, South Korea (enrolling)
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Ditmanson Medical Foundation Chia-Yi Christian Hospital — Chiayi City, Taiwan (enrolling)
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
- Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
Full record on ClinicalTrials.gov
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