Liver injury and/or liver failure
Conditions
Interventions
Test drug:Dosage form: Powder for injection
Specification: 25 mg/bottle
Administration method and dosage: Intravenous drip, administered according to the trial protocol
Duration of drug use: Single -
Placebo control:Dosage form: Powder for injection
Specification: 0 mg/bottle
Administration method and dosage: Intravenous drip, administered according to the trial protocol
Duration of drug use: Sing
Sponsors
Shenzhen Zhongke Amshenn Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects with an appropriate gender ratio. 2. Aged between 18 and 65 years (inclusive) at the time of signing the informed consent form. 3. Males should weigh at least 50 kg and females at least 45 kg. The body mass index (BMI) of all subjects should be between 19 and 26 kg/m² (inclusive). 4. Subjects should be able to understand the informed consent form, voluntarily participate in the study, and sign the informed consent form. 5. Subjects should be able to comply with the study protocol to complete the trial.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to any component of the study drug, have a history of atopic allergic diseases (such as asthma, urticaria, eczematous dermatitis), or are judged by the researcher to be at risk of allergy upon entering the study. 2. Patients with a history of any clinically serious diseases in the circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders, metabolic disorders, or any other diseases or physiological conditions that may interfere with the test results. 3. Subjects with clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram, chest X-ray (anterior view), abdominal B-ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), laboratory tests (including: complete blood count, routine urine test, blood biochemistry, coagulation function, serum IgE) at the screening stage, as judged by the researcher. 4. Subjects with a positive result in any one of the tests for HIV antibody, Treponema pallidum antibody, hepatitis B surface antigen, and hepatitis C antibody. 5. Subjects with a positive result in urine drug screening (including morphine, methamphetamine, ketamine, MDMA, THC - acid, cocaine). 6. Subjects with a history of fainting at the sight of needles or blood, or those with difficulty in venous blood collection. 7. Subjects with special dietary requirements who cannot follow the unified diet. 8. Subjects who have smoked excessively (average > 5 cigarettes per day) within 3 months before screening. 9. Subjects who have smoked within 48 hours before drug administration. 10. Subjects who have engaged in strenuous exercise within 48 hours before drug administration. 11. Heavy drinkers (i.e., men who consume more than 28 standard units of alcohol per week and women who consume more than 21 standard units of alcohol per week; 1 standard unit contains 14g of alcohol, such as 360mL of beer, 45mL of spirits with 40% alcohol content, or 150mL of wine), or subjects who have drunk alcohol regularly (i.e., more than 14 standard units per week) within 6 months before screening; or subjects with a positive result in the breath alcohol test. 12. Subjects who have a history of long-term excessive consumption of tea, coffee, or caffeinated beverages (more than 8 cups per day, 1 cup = 250mL). 13. Subjects who have consumed special diets (including grapefruit, chocolate, tea, cola, or any caffeinated food or beverage, alcoholic beverage, or other food or beverage that affects drug absorption, distribution, metabolism, and excretion) within 48 hours before drug administration. 14. Subjects who have donated blood or lost more than 450mL of blood within 3 months before screening. 15. Subjects who have taken any prescription drugs, over-the-counter drugs, functional vitamins, or Chinese herbal products within 14 days before screening. 16. Subjects who have received a vaccination within 4 weeks before drug administration or plan to receive a vaccination during the study period. 17. Subjects who have used any drugs that inhibit or induce the liver drug - metabolizing enzyme CYP3A4 within 30 days before screening (e.g., inducers - phenobarbital, rifampicin, carbamazepine, phenytoin sodium, glucocorticoids, etc.; inhibitors - ketoconazole, itraconazole, cimetidine, clarithromycin, verapamil, erythromycin, etc.). 18. Subjects with a history of drug abuse within the past 2 years (including the u
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PK parameters;Immunogenicity;TRAIL concentration; | — |
Primary
| Measure | Time frame |
|---|---|
| Maximal tolerance dose; | — |
Countries
China
Contacts
Public ContactZhongyuan Xu/Jinlin Hou
Nanfang Hospital, Southern Medical University
Outcome results
None listed