Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment

Exclusion Criteria

• •Subjects who meet any of the following criteria should not be enrolled in this study.
• •1. Subjects with an allergic constitution, including a history of severe drug allergy or drug allergic reactions, who are known to be allergic to the investigational drug or its excipients (glycerol, phenol, m-cresol, zinc acetate dihydrate, sodium chloride, and citric acid monohydrate);
• •2. Subjects with decompensated cardiac failure (NYHA Class III or IV) or those diagnosed with or highly suspected of having unstable angina pectoris or acute myocardial infarction, as well as those with malignant arrhythmias (such as ventricular fibrillation and sustained ventricular tachycardia) within 3 months before screening; subjects with a history of heart valve replacement surgery, coronary artery bypass grafting, or other invasive cardiovascular procedures, including percutaneous coronary intervention, as well as those who have experienced ischemic or hemorrhagic strokes (excluding lacunar infarctions) or transient ischemic attacks within 6 months before screening;
• •3. Subjects with any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring systemic anti-infective therapy at screening (excluding hepatitis B and C in the hepatic impairment group), those with a history of severe active infection within 1 month before screening, or those who developed any acute infection requiring systemic anti-infective therapy within 2 weeks predose;
• •4. Subjects with a history of drug abuse or drug addiction within 1 year before screening. Additionally, subjects with a positive urine drug abuse screening result predose (that cannot be attributed to concomitant medication) or a positive alcohol screening result;
• •5. Subjects who are heavy smokers or alcohol consumers within 6 months before screening (consuming ≥ 14 units of alcohol per week: 1 unit ≈ 360 mL of beer, 45 mL of spirits, or 150 mL of wine; smoking ≥ 5 cigarettes per day), or those unable to abstain from smoking and alcohol for 48 h predose and during the study;
• •6. Subjects who ingest grapefruit juice, food or beverage rich in methylxanthine (such as coffee, tea, cola, chocolate and functional drinks) within 7 days prior to dosing, or have strenuous exercise and other factors affecting drug absorption, distribution, metabolism and excretion, and cannot withdraw during the study;
• •7. Pregnant or lactating women, women of child-bearing potential (WOCBP) with positive pregnancy test results at screening, or female subjects who have engaged in unprotected sexual intercourse within 2 weeks before screening;
• •8. Subjects who are unwilling or unable to comply with the study procedures specified in the protocol, or who are deemed unsuitable for participating in this clinical study by any investigator.
• •9. Subjects with hepatic impairment ：Subjects with a history of chronic or serious diseases in the circulatory system, digestive system, urinary system, immune system, blood system, endocrine and metabolic system, or mental and nervous system, or those who have the above conditions at screening that may interfere with the study results.