mild hepatic impairment moderate hepatic impairment normal hepatic function
Conditions
Interventions
normal hepatic function:SYHX1901
Moderate hepatic impairment (Child-Pugh Class B):SYHX1901
Mild hepatic impairment (Child-Pugh Class A):SYHX1901
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria for Participants with Hepatic Impairment (All 7 criteria must be met): (1) The participant fully understands the purpose, nature, methods of the trial and potential adverse reactions, voluntarily agrees to participate in the trial, signs the informed consent form personally prior to initiation of any study procedures, and guarantees personal participation in all study procedures. (2) Aged between 18 and 75 years old (inclusive); both male and female participants are eligible. (3) Body weight >= 45.0 kg (female) or >= 50.0 kg (male); Body Mass Index (BMI) ranges from 19.0 to 32.0 kg/m^2 (inclusive). BMI = body weight (kg) / height (m)^2. (4) No medications administered within 2 weeks prior to screening, or receiving stable medication for hepatic impairment and/or other concomitant diseases for at least 4 weeks. (5) Participants with mild (Class A) or moderate (Class B) hepatic impairment per Child-Pugh classification, and cirrhosis caused by primary liver disease (such as viral hepatitis, alcoholic liver disease, metabolic dysfunction-associated steatotic liver disease (MASLD), etc.) confirmed by medical history, clinical manifestations and auxiliary examinations. The diagnostic basis for cirrhosis includes: liver biopsy pathology report obtained within the previous 6 months indicating cirrhosis; or imaging examinations (abdominal ultrasound, liver stiffness measurement (LSM), CT or MRI) showing typical manifestations of cirrhosis supported by clinical and laboratory examinations; or non-invasive liver fibrosis testing results suggestive of cirrhosis supported by clinical manifestations. Refer to Section 13.4 for diagnostic criteria of cirrhosis. (6) Participants of reproductive potential and their partners agree to use effective non-hormonal contraceptive measures (such as abstinence, condoms, inert intrauterine devices, female barrier methods (cervical cap or diaphragm with spermicide, vaginal contraceptive ring, etc.)) from the time of informed consent signature until 28 days after the last study drug administration, or have adopted permanent contraceptive measures (such as bilateral tubal ligation, vasectomy, etc.). Male participants have no plan to donate sperm from informed consent signature until 28 days after the last dose; female participants have no plan to donate ova from informed consent signature until 28 days after the last dose. (7) The investigator judges that the participant's liver function is stable based on clinical manifestations (no obvious deterioration for at least 4 weeks prior to screening), and the participant is suitable to participate in this study as assessed by the investigator based on medical history, vital signs, physical examination, laboratory tests, imaging examinations and other evaluations. 2. Inclusion Criteria for Participants with Normal Hepatic Function (All 6 criteria must be met): (1) The participant fully understands the purpose, nature and methods of the trial as well as potential adverse reactions, voluntarily agrees to participate as a study participant, personally signs the informed consent form prior to the initiation of any study procedures, and guarantees personal attendance at all study procedures. (2) Participants aged 18 to 75 years old (inclusive); both males and females are eligible (to be matched with the hepatic impairment group in terms of age and gender). (3) Body weight >= 45.0 kg (female) or >= 50.0 kg (male); Body Mass In
Exclusion criteria
Exclusion criteria: 1. Any participant meeting any of the following conditions will be excluded: (1) Known or suspected allergy to the investigational drug or any of its components, history of severe allergy, or allergy-prone; (2) Having mental illness, kidney disease, nervous system disease, or any other systemic disease that the investigator believes may affect the trial results; (3) History of shingles or tuberculosis; (4) History of acute respiratory or systemic infection within 2 weeks before signing the informed consent; (5) Used any prescription drugs, over-the-counter drugs, Chinese patent medicines, herbal medicines, vitamins, or dietary supplements within 2 weeks before signing the informed consent that are known or assessed by the investigator to significantly affect the pharmacokinetics or safety of the investigational drug; (6) Diseases that, in the investigator's judgment, affect absorption, distribution, metabolism, or excretion of the drug (e.g., acute or chronic diarrhea, acute or chronic gastritis); (7) Participation in any drug or medical device clinical trial within 3 months before signing the informed consent, and having used the investigational drug or device; (8) Previous surgeries that may affect drug absorption, distribution, metabolism, or excretion (e.g., major gastrectomy) or plans for surgeries or hospitalizations during the trial for other reasons; (9) Abnormal vital signs or ECG at screening considered clinically significant by the investigator, with potential risk from using the investigational drug; (10) Blood loss or blood donation exceeding 400 mL within 3 months before signing the informed consent; (11) Alcohol abuse: consuming more than 14 units of alcohol per week in the month before signing the informed consent (1 unit = 285 mL beer; 25 mL spirits; 150 mL wine); (12) Positive alcohol test at screening (> 0 mg/100 mL); (13) Smoking habit: average of >= 5 cigarettes per day for the 3 months before signing the informed consent; (14) Regularly consuming excessive foods or drinks containing xanthines or caffeine, or other substances affecting drug absorption, distribution, metabolism, or excretion in the month prior to screening (e.g., coffee over 1100 mL/day, tea over 2200 mL/day, cola over 2200 mL/day, energy drinks over 1100 mL/day, chocolate over 510 g/day); (15) Difficulty swallowing; (16) History of drug abuse within 1 year before signing the informed consent; (17) Positive drug screening at screening; (18) Positive for syphilis-specific antibodies or HIV antibodies; (19) Pregnant or breastfeeding women; (20) Other factors deemed by the investigator to make participation unsuitable. 2. Additional exclusion criteria for participants with liver impairment: (Applicable only to the mild/moderate liver impairment group, meeting any one condition leads to exclusion) (1) Drug-induced liver injury; (2) Autoimmune diseases or screening immunology tests suggesting possible autoimmune liver disease, including but not limited to autoimmune hepatitis, positive antinuclear antibody (ANA titer >= 1:100); (3) Acute liver damage from any cause; (4) Severe liver impairment (Child-Pugh C); (5) Liver cirrhosis with the following complications, including but not limited to overt hepatic encephalopathy, hepatocellular carcinoma, refractory ascites, active peritonitis; (6) Neutrophil count < 1.0 x 10^9/L; or platelet count < 50 x 10^9/L; or hemoglobin < 80 g/L;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK Parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety parameters; | — |
Countries
China
Contacts
Public ContactJing Zhang
Huashan Hospital, Fudan University
Outcome results
None listed