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NCT07096193 · ClinicalTrials.gov registry record · Phase 1
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
A Phase 1 study of Chronic Hepatitis Delta, sponsored by Gilead Sciences.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 107
- Enrollment target
- 8
- Study locations
NCT07096193: Recruiting Phase 1 study of Chronic Hepatitis Delta, sponsored by Gilead Sciences.
NCT07096193 is a Phase 1 study of Chronic Hepatitis Delta that is actively recruiting participants, run by Gilead Sciences. The registered enrollment target is 107 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher). The trial reports 8 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07096193, a Phase 1 study of Chronic Hepatitis Delta, is actively recruiting participants, sponsored by Gilead Sciences.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 107 participants
- Enrollment target
- 8
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG GS-4321
- DRUG GS-4321 Placebo
Study Locations (8)
Other
- IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" - Chinsinau
- PMSI Clinical Republican Hospital "Timofei Mosneaga" - Chisinau
- Korea University Ansan Hospital - Ansan-si
- The Catholic University of Korea Bucheon St. Mary's Hospital - Bucheon-si
- The Catholic University of Korea, Seoul St. Mary's Hospital - Seoul
- Samsung Medical Center - Seoul
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City
California
- Investigative Site - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2025-07-31 |
| Est. Completion | 2029-02 |
| Phase | Phase 1 |
What NCT07096193 shows while recruiting
NCT07096193 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% higher).
The record links to 1 condition, with Chronic Hepatitis Delta appearing as the primary indexed condition, and to 2 interventions - of which GS-4321 is the first listed.
NCT07096193 lists 8 locations in 2 states (Other, California).
Frequently Asked Questions
What is clinical trial NCT07096193 about?
NCT07096193 is a clinical study titled "Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus". 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 st...
What is the current status of trial NCT07096193?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 107 participants. The study started on 2025-07-31. Estimated completion is 2029-02.
What conditions does trial NCT07096193 study?
This clinical trial studies the following conditions: Chronic Hepatitis Delta.
What interventions are being tested in trial NCT07096193?
The interventions under investigation include: GS-4321 (DRUG), GS-4321 Placebo (DRUG).
Who is sponsoring clinical trial NCT07096193?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07096193 being conducted?
This trial has 8 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07096193's enrollment target sits among peer trials
107 531st of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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