Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
← catalyst calendarNCT07096193 · readout ≤ 1,261 d
Sponsored by Gilead Sciences (industry) · GILD — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · Double · Treatment
Enrollment
200estimated
Sites
22
Countries
Bulgaria, Germany, Italy +5
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-31 | actual | When the study began enrolling |
| Primary completion | Jan 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2030 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Hepatitis Delta
Interventions
- Drug: GS-4321
- Drug: GS-4321 Placebo
- Drug: GS-4321
Primary outcomes
what the primary-completion date above is the date OFPhase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events
measured Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events
measured Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities
measured Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
Phase 1: Serum Pharmacokinetic (PK) parameter; AUC of GS-4321
measured First dose up to 24 Weeks
Phase 1: Serum PK Parameter: Cmax
measured First dose up to 24 Weeks
Phase 1: Serum PK Parameter: Tmax
measured First dose up to 24 Weeks
Phase 1: Serum PK Parameter: t1/2
measured First dose up to 24 Weeks
Phase 2: Proportion of Participants with Combined Response
measured Up to 96 Weeks
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