Clinical Research Directory

Inclusion Criteria: * 1\) Participants can understand the nature, purpose, procedures, possible risks and adverse reactions of this trial, and complete the trial as required. Voluntarily participate in clinical trials and sign the informed consent form before the trial commences; 2\) Male or female participants aged 18 to 70 years old on the day of signing the informed consent form (including the cut-off value); 3\) When screening, the weight of men should be ≥50kg and that of women ≥45kg. The body mass index (BMI= weight (kg)/height (m ²)) is within the range of 18.0 to 32.0 kg/m ² (including the critical value); 4\) The estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI 2021 formula (see Annex 2) is ≥ 75 mL/min/1.73m2; 5\) At the time of screening, the normal or abnormal results of vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), frontal chest X-ray or CT, and abdominal color Doppler ultrasound of the participants in the normal liver function group had no clinical significance; 6\) Participants with normal liver function and no previous serious primary diseases of vital organs, including but not limited to circulatory system, coagulation system, endocrine system, skin system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities; 7\) The demographic mean of participants in the normal liver function group at the time of screening must meet the following matching criteria: a) BMI matching was conducted with the liver dysfunction group, with the mean value within ±15% (including the critical value); b) Age matching was carried out with the liver dysfunction group, with the mean value within ±10 years (including the critical value); c) Gender matching was conducted with the liver dysfunction group, with ±1 participant/gender. 8\) Participants (including their partners) had no plans for having children, no plans for sperm or egg donation during the trial period and within 3 months after administration, and agreed to take effective contraceptive measures (for details, see Appendix 3); Patients with liver dysfunction also need to meet the following inclusion criteria: 9\) Child-Pugh grade A, B and C liver insufficiency (without albumin use within 14 days), chronic liver injury caused by previous primary liver diseases: including but not limited to non-alcoholic steatohepatitis, viral hepatitis (hepatitis B, hepatitis C), etc. 10\) Within 4 weeks before administration, the researcher determined that the liver function was stable based on clinical manifestations (Child-Pugh grade A and B); Within 2 weeks before administration, the researchers determined that the liver function was stable based on clinical manifestations (Child-Pugh grade C). 11\) Those who have not taken medication within the 4 weeks prior to screening, or have a stable medication regimen for at least 4 weeks for primary liver diseases. Exclusion Criteria: * 1\) Those who are known to be allergic to any component of the test drug or preparation, or those with an allergic constitution (such as being allergic to two or more drugs, foods or pollen, etc.); 2\) Those who have special dietary requirements and cannot accept a uniform diet; Or those who have difficulty swallowing; 3\) The average daily smoking (or the use of an equivalent amount of nicotine-containing products) within the three months prior to screening was more than five cigarettes, or smoking could not be prohibited during the trial period; 4\) Those who have a history of alcohol abuse within the three months prior to screening, that is, those who consume more than 14 units of alcohol per week (1 unit =360mL of beer or 45 ml of 40% alcohol or 150 ml of wine), or those who cannot abban alcohol during the test period, or those with a positive breath test for alcohol; 5\) Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 4 cups per day, 1 cup =250mL) within the three months prior to screening; Or those who have consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before the first administration; Or disagree to stop taking tea, coffee or foods or beverages containing caffeine during the trial period; 6\) Those who have consumed a large amount of beverages or foods rich in grapefruit (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; Or those who have consumed any beverage or food rich in grapefruit (i.e. grapefruit) within 48 hours before the first administration; Or those who do not agree to stop drinking any beverages or foods rich in grapefruit (i.e. grapefruit) during the trial period; 7\) Previously diagnosed as a malignant tumor (excluding radical resection of cutaneous basal cell carcinoma, papillary thyroid carcinoma, cutaneous squamous cell carcinoma or cervical cancer in situ); 8\) Participants previously diagnosed with periodontitis or/and palmoplantar hyperkeratosis; 9\) Those with a history of drug abuse, drug abuse or drug dependence, or with a positive screening result for drug abuse; 10\) There are obvious factors or gastrointestinal diseases that significantly affect the absorption of oral drugs, such as inability to take oral drugs or obvious nausea and vomiting, malabsorption, external biliary drainage, gastrointestinal resection, etc. 11\) Those who have donated blood or lost blood of ≥400mL within the 3 months prior to screening (excluding menstrual blood loss in women) or donated blood during the planned study period; 12\) Those who have used any drugs that inhibit or induce liver CYP enzymes within 28 days before screening or within 5 half-lives of the drugs (whichever is longer); 13\) Those who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements within 14 days prior to the administration of the investigational drug or within 5 half-lives (whichever is longer) of the drug (only participants with normal liver function); 14\) Those who have participated in any clinical trial of a drug or medical device within 3 months prior to screening and are expected to have residual effects of the trial treatment (as determined by the investigator), or are still within the follow-up period of a certain clinical trial or within 5 half-lives of the trial drug before screening (whichever is longer); 15\) Those who have received live vaccines (excluding influenza vaccines) within one month prior to screening or plan to receive attenuated live vaccines during the trial period; 16\) Those who test positive for any one of the following indicators during the screening period: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or Treponema pallidum antibody (positive results for hepatitis B virus surface antigen and hepatitis C virus antibody are acceptable for participants in the liver dysfunction group). 17\) The QTcF interval during the screening period (calculated by the formula QTcF = QT/RR0.33) is for males ≥470ms and females ≥480ms, or for those whose abnormalities are clinically significant as determined by the investigators and who are not suitable for this trial as determined by the investigators. 18\) Those who have had systemic active infections (such as respiratory or central nervous system infections, etc.), severe trauma, or major surgical operations within two weeks prior to screening; 19\) Those who are expected to have a tendency towards surgery or hospitalization other than those required by the trial during the trial period; Or participants who are expected not to complete the entire follow-up of the trial; 20\) Those with a history of fainting at the sight of needles or blood, those who have difficulty in blood collection or cannot tolerate venipuncture blood collection, or those whose physical condition cannot tolerate blood collection; 21\) Researchers determine that there are tattoos or scars on any part of the skin that affect the safety assessment. 22\) Pregnant or lactating women; Or those with positive results in pregnancy tests; 23\) Participants who were considered by the researchers to have poor compliance or other factors that made them unsuitable for this trial. For patients with liver dysfunction, the following exclusion criteria should also be added: 24\) In addition to the primary liver disease itself, there is any history of serious diseases, or any medical history and/or clinical laboratory tests of clinical significance that the researcher believes may affect the test results, including but not limited to a history of circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases; 25\) Patients currently in a state of acute liver failure Or cirrhotic patients with drug-induced liver injury, hepatic encephalopathy (Westhaven grade 2 or above), hepatocellular carcinoma (excluding those with Barcelona stage 0 or those who have achieved radical treatment), current patients with esophageal and gastric variceal bleeding, or those who have undergone portosystemic shunt within half a year and other complications considered unsuitable by researchers; 26) Participants who had been using systemic hormones (excluding those stably using prednisone at a dose of ≤ 5 mg/ day or an equivalent dose of glucocorticoids) or other immunosuppressants within 4 weeks before screening, or those who were still within the drug efficacy period more than 4 weeks after the last immunosuppressive treatment at the time of screening (as evaluated by the investigators); 27\) Alpha-fetoprotein \&gt 20 ng/mL; Hemoglobin ≤70 g/L; Those with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 times the upper limit of the normal value (ULN) There was severe active bleeding or platelet level ≤50×109/L (Child-Pugh grade A, B) or platelet level ≤30×109/L (Child-Pugh grade C) during screening (except for cases judged by the researcher to be in a stable state); 28\) Has a history of liver transplantation.