Clinical Trial

Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial plans to enroll approximately 24 MASLD participants across four dose cohorts, each consisting of 6 participants who will receive oral ACT500 once daily.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-04.
Trial Details
NCT Number NCT07462455
Lead Sponsor Xiamen Amoytop Biotech Co., Ltd.
Collaborators: Beijing Tsinghua Changgeng Hospital
Conditions Metabolic Dysfunction-associated Steatohepatitis
Enrollment 24 participants
Start Date 2026-03-31
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-17