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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 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. The trial reports 8 study locations across 2 states.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07096193
The ClinicalTrials.gov registry entry for NCT07096193 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Related
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