Condition: Chronic Hepatitis Delta · Sponsor: Gilead Sciences
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.
This description comes directly from the study's public registry record.
Gilead Clinical Study Information Center · 1-833-445-3230 (GILEAD-0) · GileadClinicalTrials@gilead.com
Always discuss trial participation with your own doctor first.
| Investigative Site | Anaheim, California, United States | Recruiting |
| University of Louisville, Clinical Trials Unit | Louisville, Kentucky, United States | Recruiting |
| University of Maryland, Institute of Human Virology, Clinical Research Unit | Baltimore, Maryland, United States | Recruiting |
| The New York-Presbyterian Hospital | New York, New York, United States | Recruiting |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia | Milan, Italy | Recruiting |
| IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" | Chinsinau, Moldova | Recruiting |
| IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" | Chisinau, Moldova | Recruiting |
| PMSI Clinical Republican Hospital "Timofei Mosneaga" | Chisinau, Moldova | Recruiting |
| Institutul National De Boli Infectioase Prof. Dr. Matei Bals | Bucharest, Romania | Recruiting |
| Fundatia Dr. Victor Babes | Bucharest, Romania | Recruiting |
| Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals | Bucharest, Romania | Recruiting |
| Gastromedica S.R.L. | Iași, Romania | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07096193