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Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

RecruitingPhase 1/2Healthy volunteers welcome

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

Who can join

Ages 18 to 69 · All sexes · Healthy volunteers welcome

Full eligibility criteria
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.
* Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.
* Non-cirrhotic or compensated cirrhosis.
* Hepatitis delta virus ribonucleic acid (HDV RNA ) \> 500 IU/mL at screening.
* Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening.

Key Exclusion Criteria:

Part A:

* Positive serum or urine pregnancy test.
* Participants with plans to breastfeed during the study period.

Part B:

* Positive serum or urine pregnancy test.
* Participants with plans to breastfeed during the study period.
* Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.
* Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

About the study

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.

What is being tested

Sponsor: Gilead Sciences · Participants: 200 · Started: Jul 31, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07096193

Locations in the U.S.

CaliforniaInvestigative Site, Anaheim
University of California, San Diego - Altman Clinical and Translational Research Institute, La Jolla
KentuckyUniversity of Louisville, Clinical Trials Unit, Louisville
MarylandUniversity of Maryland, Institute of Human Virology, Clinical Research Unit, Baltimore
New YorkThe New York-Presbyterian Hospital, New York

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.