This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo.
Sign an informed consent form before the experiment and fully understand the content, process, and potential adverse reactions of the experiment;
Voluntarily comply with the experimental requirements and conduct follow-up visits on designated dates, demonstrating good adherence to the protocol; And voluntarily maintain the original lifestyle (diet and exercise habits) during the study period without changing.
Participants (including partners) agree to take effective contraceptive measures throughout the study period until 6 months after discontinuation of medication;
Male and female patients aged 18 to 65 years old (including 18 and 65 years old);
Excessive alcohol consumption for three consecutive months or more within the year prior to screening (men consume an average of over 30 grams of ethanol per day, equivalent to 3.75 units of alcohol, and women consume over 20 grams, equivalent to 2.5 units of alcohol: 1 unit=285 mL of beer, 25 mL of spirits, or 100 mL of wine);
Individuals with allergies (to multiple drugs or foods);
Donate blood or experience significant blood loss (>450 mL) within the first three months of screening;
Individuals with a history of weight loss surgery or those who are planning to undergo weight loss surgery recently;
Parallel
IMM-H014
DrugEach group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1, once a day for a total of 12 weeks.
Placebo
DrugEach group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1, once a day for a total of 12 weeks.
Adverse Events following oral doses of IMM-H014 and placebo
the adverse events are recorded according to the actual occurrence
Number of participants with abnormal laboratory tests results and abnormal physical exam findings
the adverse events are recorded according to the actual occurrence
PK parameters: AUCinf（AUC0-∞）
AUClast is defined as the concentration of drug from time zero to the last quantifiable concentration.
PK parameters: Cmax
Cmax is defined as the maximum observed concentration of drug in plasma.
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