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 meetone of the following criteria: ：(1) ALT ≥5 ×ULN；(2) ALP ≥2× ULN；(3) ALT≥3× ULN andTBil ≥2×ULN.
3. ALP ≥2× ULN, and conform to the clinical classification of cholestatic type ormixed type DILI in the Chinese Guidelines for the Diagnosis and Treatment ofDrug-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 hepatitisA, B, C, E, autoimmune hepatitis, biliary tract disease, PBC, etc. (Exclusivediagnostic tests completed in our hospital or other hospitals after this suspectedacute 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 isnecessary to evaluate the causal relationship by three experts according to theevaluation criteria of expert opinions in the Chinese Guidelines for the Diagnosis andTreatment of Drug-induced Liver Injury (2023 edition), and at least two expertsdetermine 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 forthe 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 beforebeing enrolled, or at least 1 year after pausimenia, or permanent sterilization ≥6weeks（There should have a recording of hysterectomy, bilateral salpingo-oophorectomy）.The female and their male partners with the fertility potential agree to utilize theeffective contraceptive methods（the following two methods can be selected: 1. any ofthe condom, diaphragm, Sponge or Cervical Cap with with Spermicide ）.
9. Fully understand the study process of the clinical trial, and provide the signedICF of joinning the clinical trial.

Exclusion Criteria:

• 1. Acute or chronic liver failure or liver decompensation

2. The history of liver decompensation or portal hypertension history
3. Moderate or above renal insufficiency, creatinine clearance (Ccr) < 60mL/min (according to the MDRD formula).
4. Patients with serious diabetes and had poor control of blood sugar (HbA1c>10%)
5. Serious sysmetic diseases of cardiovascular, respiratory, neurological, urinary,digestive, and for any reason which, in the opinion of the Investigator think thesubject is not suitable for participating in the study.
6. The predict survival period < 6 months.
7. Utilization of Perursodeoxycholic acid within 14 days before the treatment.
8. Utilization of S-adenosylmethionine within 1 days before the treatment.
9. The patients must regularly utilize the known strong CYP3A4/3A5 inhibitors such asClarithromycin, Itraconazole, ketoconazole, Ritonavir, rifampicin, phenytoin,carbamazepine within 1 week before the treatment or for the whole study period.
10. Allergies or intolerances to study drug ingredients
11. Patients are under the gestation, lactation, or patients have the pregnancyplanning during the study period and 90 days after the end of the clinical trial
12. Patients are not willing to ban the alcohol during the study period.
13. Patients had joined the other clinical trials within 3 months before theadministration.
14. Other conditions that the investigator think the subject is not suitable forparticipating in the study.