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Study identifier: NCT07589400 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Not Yet Recruiting

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

Condition: Metabolic Dysfunction-associated Steatotic Liver Disease · Chronic Hepatitis b  ·  Sponsor: Xiamen Amoytop Biotech Co., Ltd.

PhasePhase 1
Planned participants24
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNo

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About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Jidong Jia, Ph.D  ·  13501378269  ·  jia_jd@ccmu.edu.cn

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Locations (4)

Beijing Friendship Hospital, Capital Medical UniversityBeijing, China
Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, China
The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, China
Xiamen Hospital of Traditional Chinese MedicineXiamen, China

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