Clinical Trial

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis B

Not Yet Recruiting Phase 1
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Summary
This study is a Phase Ib, multicenter randomized, double-blind, dose-escalation, placebo-controlled trial designed to evaluate the safety, tolerability, PK, and PD profiles of multiple-dose ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated with chronic hepatitis B (CHB). The trial plans to enroll 24 participants with MASLD complicated with CHB across three dose cohorts initially, each consisting of 8 participants who will receive oral ACT500 tablets once daily.
Trial Details
NCT Number NCT07589400
Lead Sponsor Xiamen Amoytop Biotech Co., Ltd.
Conditions Metabolic Dysfunction-associated Steatotic Liver Disease, Chronic Hepatitis b
Enrollment 24 participants
Start Date 2026-05-30
Primary Completion 2027-03-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-15