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
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- Yes
Key Inclusion Criteria: Part A: * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission. Part B: * Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history. *…
Interventions
- DrugGS-4321
Administered subcutaneous (SC) or intravenously IV
- DrugGS-4321 Placebo
Administered SC
- DrugGS-4321
Administered SC
Locations (15)
- Investigative SiteAnaheim, California
- University of Maryland, Institute of Human Virology, Clinical Research UnitBaltimore, Maryland
- The New York-Presbyterian HospitalNew York, New York
- IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba"Chinsinau
- PMSI Clinical Republican Hospital "Timofei Mosneaga"Chisinau
- Institutul National De Boli Infectioase Prof. Dr. Matei BalsBucharest