• （1）The first stage:

• Participants who meet all of the following criteria will be enrolled in the study:

⁃ Age ≥18 and ≤60 years old, gender is not limited;

⁃ Patients with liver injury clinically diagnosed with hepatocyte injury or mixed liver injury or CHB patients with hepatitis B virus infection for more than 6 months (refer to the Chronic Hepatitis B Prevention and Treatment Guidelines (2019 edition)). Screening patients with CHB may provide etiological (HBsAg positive and/or HBV DNA positive) or clinical or pathological evidence (liver tissue biopsy results) that HBV infection has been present for more than 6 months.

⁃ Serum ALT: 2\

• 10× upper limit of normal (ULN), TBil: \<5×ULN;

⁃ DILI patients: the abnormal duration of liver biochemical indexes \[ALT, AST, ALP, gamma-glutamyltranspeptides (GGT), TBil, albumin, prothrombin time\] does not exceed 90 days;

⁃ The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last test drug administration;

⁃ Sign informed consent and be able to comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.

• (2)The second stage:

• Subjects meeting all of the following criteria will be included in the study:

⁃ Age ≥ 18 and ≤ 65 years old, with no gender restrictions;

⁃ According to the Chinese Guidelines for the Diagnosis and Treatment of Drug-Induced Liver Injury (2023 Edition), patients diagnosed with drug-induced liver injury (DILI) or those diagnosed with intrahepatic cholestasis type liver injury. Patients with DILI and intrahepatic cholestasis type liver injury need to meet the following criteria separately;

∙ Patients with DILI need to simultaneously meet the following conditions: ① Serum ALT \> 3 times the upper limit of normal (ULN), and TBil \> 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L according to international standards); ② Abnormal liver biochemical indicators (ALT, AST, ALP, TBil) persist for no more than 60 days;

‣ Patients with intrahepatic cholestasis type liver injury need to simultaneously meet the following conditions: ① TBil \> 2 times the ULN (the ULN of TBil refers to 17.1 μmol/L); ② ALP \> 1.5 times the ULN; ③ALT\>1×ULN;

⁃ The subjects (including their partners) are willing to voluntarily adopt effective contraceptive measures from the time of the initial screening until 6 months after the last administration of the investigational drug;

⁃ They have signed the informed consent form and can comply with the requirements of the protocol; if the subjects are unable to sign the informed consent form, it must be signed by a legal guardian or a witness as required by the regulations.

• The third stage:

• Subjects who meet all of the following criteria will be enrolled in the study:

• 1\. Age ≥18 and ≤70 years old, gender is not limited; 2. Patients diagnosed with chronic and acute liver failure with TBil≥5×ULN according to the Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition) may have hepatic encephalopathy (Grade 1-2) or ascites (grade 1-2) 4 weeks before subject screening. And 5≤AARC score ≤10 (AARC rating I-II); 3. The subject (including the partner) is willing to take effective contraceptive measures from the screening until 6 months after the last trial drug administration; 4. Sign informed consent and comply with the requirements of the program; If the subject is unable to sign the informed consent form, it must be signed by a legal guardian or witness as required by the regulations.

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