NCT07096193 Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
| NCT ID | NCT07096193 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Gilead Sciences |
| Condition | Chronic Hepatitis Delta |
| Study Type | INTERVENTIONAL |
| Enrollment | 107 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 107 participants in total. It began in 2025-07-31 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 ) \> 100 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.
Contact & Investigator
Gilead Clinical Study Information Center
✉ GileadClinicalTrials@gilead.com📞 1-833-445-3230 (GILEAD-0)
Gilead Study Director
STUDY DIRECTOR
Gilead Sciences
Frequently Asked Questions
Who can join the NCT07096193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chronic Hepatitis Delta. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07096193 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07096193 currently recruiting?
Yes, NCT07096193 is actively recruiting participants. Contact the research team at GileadClinicalTrials@gilead.com for enrollment information.
Where is the NCT07096193 trial being conducted?
This trial is being conducted at Anaheim, United States, Baltimore, United States, New York, United States, Chinsinau, Moldova and 11 additional locations.
Who is sponsoring the NCT07096193 clinical trial?
NCT07096193 is sponsored by Gilead Sciences. The principal investigator is Gilead Study Director at Gilead Sciences. The trial plans to enroll 107 participants.