hepatic ascites
Conditions
Interventions
Group 2:Placebo
Sponsors
Beijing Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adults, aged 18-55 years (including the critical value), no gender limit; 2. Those who weigh >=45 kg and have a body mass index (BMI) between 18 and 28 kg/m^2 (including the critical value); 3. During the whole study period (from screening to 3 months after the end of the test), patients or their spouses voluntarily took effective contraceptive measures, such as abstinence, condoms, IUDs, double barrier methods (such as condoms and contraceptive diaphragms), etc., there is no sperm donation plan for men; 4. Those who voluntarily participate in clinical trials and sign the informed consent; 5. Those who can communicate well with researchers and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. Yeast-derived antibody positive; 2. Those with clinically significant drug or food allergy, allergic disease history or allergic constitution (allergies to >= 2 substances), or those who are clearly allergic to this product or its similar albumin preparations; 3. Have a history of serious clinical diseases, including but not limited to circulatory system, endocrine system, gastrointestinal tract, kidney, nervous system, blood system, immune system, mental disease and metabolic abnormality, etc. and the researchers believe that they are not suitable to participate in clinical trials; 4. History of cardiovascular system diseases, including but not limited to abnormal vital signs (such as systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, heart rate 100 bpm), severe arrhythmia, heart failure, unstable angina, myocardial infarction within the last 6 months before screening, history of tachycardia/bradycardia requiring drug therapy, third-degree atrioventricular block, QTc interval >= 450 ms or clinically significant abnormalities in ECG; 5. Those who have suffered from chronic infectious diseases in the past and may affect the evaluation of the trial drug as judged by the investigator; 6. Those who have suffered from clinically significant diseases or received surgical operations within 4 weeks before administration; 7. Difficulty in collecting blood or unable to tolerate venipuncture, and those with a history of fainting from needles and haemorrhages; 8. Those who are positive in alcohol breath test, tobacco test or drug urine screening test; 9. Physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (blood routine, urine routine, blood biochemical examination, etc.) found to have clinically significant abnormalities; 10. One or more of the test results of human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis B surface antigen or hepatitis C antibody are positive; 11. Have a history of substance abuse, drug or alcohol abuse (i.e. drinking more than 14 units of alcohol per week [1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine]) or smoking history (>=5 cigarettes per day), or those who cannot smoke during hospitalization; 12. Use any caffeine-rich food or drink (coffee, tea, cola, chocolate, etc.) within 48 hours before the first administration of the study drug, or do not agree to prohibit the use of caffeine-rich food or drink during the trial; 13. Those who have special requirements for diet and cannot comply with the unified diet; 14. Those who have received corticosteroids or human plasma products within 4 weeks before the administration of the test drug, and have used any prescription drugs, non-prescription drugs or herbal medicines within 2 weeks (except topical preparations or topical preparations); 15. Those who participated in any drug clinical trials within 3 months before administration; 16. Those who have donated blood within 4 weeks before administration or plan to donate blood (>400 mL) during the study or within 4 weeks after the end of the study; 17. Patients during pregnancy and lactation; 18. The researchers believe that the compliance is poor, or there are other factors that are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;PK evaluation index;PD evaluation index;Anti-drug antibody; | — |
Countries
China
Contacts
Public ContactHu Bei
Beijing Union Medical College Hospital
Outcome results
None listed