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.
The participant fully understands the purpose, nature, methods of the trial, and the potential adverse reactions, voluntarily agrees to participate in this study, and signs the informed consent form.
Male or female participants aged between 18 and 60 years (inclusive) at the time of signing the informed consent form.
Liver fat content ≥10% as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) during the screening period.
Liver stiffness measurement (LSM) by FibroScan during the screening period meets 8 kPa ≤ LSM < 12 kPa, or liver biopsy results within 6 months prior to screening show stage F2/F3 liver fibrosis.
Concurrent other liver diseases, including but not limited to hepatitis C, hepatitis D, drug-induced liver disease, alcoholic liver disease, autoimmune liver disease, suspected or confirmed liver cancer, etc.
Participants with a previous or current history of other malignant tumors, liver cirrhosis (including imaging-confirmed or suspected cirrhosis, and liver biopsy-confirmed cirrhosis), or evidence of decompensated liver disease (such as ascites, esophagogastric variceal bleeding, hepatic encephalopathy), or with a history of liver transplantation.
Participants with a history or current symptoms of severe cardiovascular and cerebrovascular diseases, including but not limited to uncontrolled or severe arrhythmia (ventricular fibrillation, atrial fibrillation, etc.), myocardial infarction, coronary heart disease, uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg).
Participants with persistent and clinically significant medical history of respiratory, nervous, gastrointestinal, immune, hematological or psychiatric diseases, which, in the opinion of the investigator, may impose additional risks on the participant.
6
Treatment groupsSee each treatment group below.
Xiamen Amoytop Biotech Co., Ltd.
Lead sponsor