A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects

Inclusion Criteria

• •1\. 18≤ age ≤ 75 years, male or female.
• •2\. When diagnosis of acute DILI, the liver biochemical threshold of patients must meet one of the following criteria: ：(1) ALT ≥5 ×ULN；(2) ALP ≥2× ULN；(3) ALT≥3× ULN and TBil ≥2×ULN.
• •3\. ALP ≥2× ULN, and conform to the clinical classification of cholestatic type or mixed type DILI in the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition) (cholestatic type: R value ≤2; Mixed type: 2\<R value \<5).
• •4\. Excluded other common causes of acute liver injury, such as acute viral hepatitis A, B, C, E, autoimmune hepatitis, biliary tract disease, PBC, etc. (Exclusive diagnostic tests completed in our hospital or other hospitals after this suspected acute DILI event or within 2 months before screening were acceptable)
• •5\. RUCAM causality scale score ≥6 points; If the RUCAM score is between the 3-5 it is necessary to evaluate the causal relationship by three experts according to the evaluation criteria of expert opinions in the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition), and at least two experts determine that the liver injury of the patients are "likely", "very likely" or "definitely" caused by drugs.
• •6\. The serious level of DILI is within level 1-2 based on the Chinese Guidelines for the Diagnosis and Treatment of Drug-induced Liver Injury (2023 edition).
• •7\. The duration of this liver injury is less than 6 months.
• •8\. The female with fertility must have had a negative pregnancy test results before being enrolled, or at least 1 year after pausimenia, or permanent sterilization ≥6 weeks（There should have a recording of hysterectomy, bilateral salpingo-oophorectomy）. The female and their male partners with the fertility potential agree to utilize the effective contraceptive methods（the following two methods can be selected: 1. any of the condom, diaphragm, Sponge or Cervical Cap with with Spermicide ）.
• •9\. Fully understand the study process of the clinical trial, and provide the signed ICF of joinning the clinical trial.