Clinical Trial

ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis B (CHB)

Not Yet Recruiting Phase 1
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Summary
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial consisting of two parts. Part 1 includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts conducted in healthy participants. Part 2 is a multiple ascending dose (MAD) trial enrolling HBeAg-negative chronic hepatitis B (CHB) participants with suppressed HBV DNA under stable nucleos(t)ide analog (NA) therapy.
Trial Details
NCT Number NCT07741461
Lead Sponsor Xiamen Amoytop Biotech Co., Ltd.
Collaborators: Huashan Hospital
Conditions Chronic Hepaititis B
Enrollment 72 participants
Start Date 2026-08
Primary Completion 2027-03 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-03