Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
128actual
Sites
10
Countries
Hong Kong, Italy, Moldova +4
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 | 2023-08-30 | actual | When the study began enrolling |
| Primary completion | 2025-12-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-02-09 | actual | The whole study's end, after follow-up |
| First posted | 2023-07-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-13 | 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 b
Interventions
- Drug: AB-101
- Drug: Placebo
- Drug: Nucleos(t)ide Analogue
Primary outcomes
what the primary-completion date above is the date OFParts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
measured [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
measured [Time Frame: Up to 196 days]
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
measured [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
measured [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
measured [Time Frame: Up to 196 days]
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
measured [Time Frame: Up to 196 days]
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