A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
40actual
Sites
1
Country
New Zealand
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 | 2025-01-31 | actual | When the study began enrolling |
| Primary completion | 2025-07-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-08 | actual | The whole study's end, after follow-up |
| First posted | 2024-12-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Hepatitis Delta Virus
- Hepatitis D
Interventions
- Drug: ABI-6250
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFProportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Maximum Observed Plasma Concentration (Cmax) of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Time to Cmax (Tmax) of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Systemic Clearance (CL/F) of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Volume of Distribution (Vz/F) of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
Dose normalized AUCs and Cmax of ABI-6250
measured From enrollment to 10 days after the last dose, at pre-specified timepoints
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