Inclusion Criteria:
All participants must meet all of the following conditions:
- Voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and be willing to strictly follow the clinical study protocol to complete this study;
- The subjects agree to have no plans to conceive or donate sperm/eggs within 6 months from the signing of the informed consent form until the last administration, and voluntarily adopt effective contraceptive measures (non-pharmacological contraceptive measures were taken during the study period, as detailed in Appendix 1);
- On the day of signing the informed consent form, both males and females must be at least 18 years old;
- The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
- Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min.
Subjects with normal hepatic function must also meet all of the following conditions:
1) When screening, the following demographic matching criteria must be met:
- BMI matching with the matched hepatic impairment group, with a mean within ± 15% range;
- Age matching with the matched hepatic impairment group, with a mean of ± 5 years;
- Gender matching with the matched hepatic impairment group,with the same number of individuals for each gender;
Subjects with liver dysfunction must also meet all of the following conditions:
- Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) in subjects with hepatic impairment classified as A or B by Child Pugh grading (see Appendix 3 for Child Pugh grading).
- Researchers determine that the hepatic function status of the subjects has been stable for at least 2 months based on their clinical symptoms and other examination results available during screening (as determined by the researchers).
- Individuals who have a stable medication regimen for treating hepatic impairment, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not require adjustment (including medication type, dosage, or frequency, except for diuretics, insulin, and other medications); Or those who have not taken medication.
Exclusion Criteria:
Subjects with normal hepatic function should be excluded if they meet any of the following exclusion criteria:
- History of liver injury;
- Individuals who have previously or currently suffered from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with the test results;
- Abnormalities in physical examination, vital signs, laboratory tests, 12 lead electrocardiogram, chest X-ray, abdominal ultrasound, and other examinations have clinical significance as determined by the researchers;
- Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen/antibody or Treponema pallidum antibody;
- Individuals who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical preparations that exert local effects) within 14 days prior to drug administration.
If a subject with hepatic impairment meets any of the following exclusion criteria, they should be excluded:
- The subject has any of the following conditions: ①Having undergone liver transplantation in the past; ② Having undergone partial hepatectomy in the past; ③ Patients who are suspected of or diagnosed with liver cancer or other malignant tumors (except for specific cancers that have been surgically removed and completely cured, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; except for patients with liver cancer who have received radical treatment and have no recurrence; except for patients with liver cancer at BCLC stage 0);④ Patients with liver failure; ⑤ Those who had rupture and bleeding of esophageal and gastric varices within 3 months before screening; ⑥ Patients with biliary cirrhosis, extrahepatic biliary obstruction and other diseases, and who are deemed by the investigator as not suitable to participate in this trial;
- The laboratory test results during screening meet any of the following criteria: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>10 × ULN; (b) Absolute neutrophil count (NE #)<0.75 × 109/L; (c) Hemoglobin (HGB)<60 g/L; (d) Alpha fetoprotein (AFP)>100 ng/mL;
- Individuals who test positive for HIV antigen/antibody screening; If the Treponema pallidum antibody is positive, the Rapid Plasma Reactive Protein (RPR) test should be added. If RPR is also positive, it should be excluded;
- In addition to the primary liver disease itself, those who have previously or currently suffered from other serious organ systemic diseases, including but not limited to uncontrollable gastrointestinal, respiratory, renal, neurological, blood, endocrine, tumor, immune, psychiatric or cardiovascular diseases, or clinical laboratory tests that have clinical significance and have been determined by the research doctor to be unsuitable for participation in this study.