A Phase I Clinical Study of AHB - 171 in Healthy Participants(HP) and Chronic Hepatitis B (CHB) Participants
NCT07511218 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2026-04-06
Summary
The goal of this clinical trial is to evaluate the safety, tolerability, immunogenicity and Pharmacokinetics (PK) characteristics of AHB-171 Injection in healthy participants (Part A) and participants with chronic hepatitis B (CHB, Part B), and assess its preliminary efficacy in CHB participants.
Conditions
- Chronic Hepatitis B Infection
Interventions
- DRUG
-
AHB-171 Injection
AHB-171 Injection is adminstrated via subcutaneous injection
- DRUG
-
Placebo is admistrated via subcutaneous injection
- DRUG
-
Nucleos(t)ide Analogue (NA)
Oral administration
Sponsors & Collaborators
-
Ausper Biopharma Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2027-12-30
- Completion
- 2028-06-30
Countries
- China
Study Locations
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