For the treatment of some viral diseases, such as acute and chronic viral hepatitis, herpes zoster, condyloma acuminatum
Conditions
Interventions
1:The intervention should read, "Injection of recombinant human interferon alpha 2B subcutaneously at 2 million IU per dose, one dose.
Sponsors
Nanning First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 60 years old (including 18 and 60 years old), male and female; 2. Male weight >= 50.0kg, female weight >= 45.0kg; Body mass index (BMI) was within the range of 19 ~ 26 kg/m2 (including the critical value). 3. Subjects are free from any cardiovascular, respiratory, renal, gastrointestinal, liver, metabolic, endocrine, immunological, neurological or mental diseases of clinical significance and are in good general health; 4. Subjects who have completed all the tests before administration, and the test results are deemed normal or abnormal by the researcher to have no clinical significance; 5. Agrees to have no family planning during the study period and for at least 6 months after the last study drug administration, to voluntarily take effective contraceptive measures and to have no plan to donate sperm or eggs; 6. Subjects can have good communication with the researcher, understand and comply with the requirements of this study, understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with any acute or chronic disease (including infectious disease) related symptoms before administration; 2. History of epilepsy or unexplained syncope; 3. Persons who are known or suspected to be allergic to this product or its preparation ingredients, or who have a history of allergy to two or more other drugs and are highly sensitive to food and environmental substances, or are currently suffering from atopic allergic diseases (asthma, urticaria, eczema dermatitis); 4. Use any non-prescription or prescription drugs, proprietary Chinese medicines, or health products 14 days before the use of the research drugs; 5. Any drugs, inducers, such as rifampicin, barbiturates, carbazepine, phenytoin, glucocorticoids, omeprazole, that inhibit or induce liver drug metabolizing enzymes were used 30 days before the test;Inhibitors such as SSRI antidepressants, cimetidine, sedative and hypnotic drugs, verapamil, fluoroquinolones, antihistamines; 6. Positive results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody and syphilis antibody; 7. A history of alcohol abuse, i.e. drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL 40% spirits or 150mL wine) in the 6 months prior to the trial, or a positive breathalyzer test; 8. Smoking at least 5 cigarettes or its equivalent per day and not stopping the use of any tobacco products during the study period; 9. Excessive consumption of strong tea, strong coffee and/or caffeinated beverages (8 cups or more, 1 cup =250mL) per day; 10. Consume chocolate or any food or drink containing caffeine, theophylline, theobromine or alcohol within 48 hours before the use of the study drug; 11. Those who have special dietary requirements, fail to comply with the provided diet and corresponding regulations, and have consumed grapefruit (grapefruit) fruits, products containing grapefruit (grapefruit), mango, pitaya and other ingredients within 48 hours before the use of the study drug; 12. Screening blood donation or blood loss of more than 400mL in the first 3 months; 13. Participated in any clinical trial and took the experimental drug within 3 months prior to the trial; 14. A history of drug abuse or positive drug screening (urine test); 15. Pregnant or lactating women or those with positive pregnancy test before drug administration; 16. Patients with venous difficulty; 17. Vaccination within 4 weeks before administration; 18. Those deemed unfit to participate in the experiment by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The AUC0- t pharmacokinetic evaluation parameter;Peak concentration (Cmax);Area under Neopterin Neopterin pharmacodynamics curve PDAUEC and peak effect PDmax;Area PDAUEC and peak effect PDmax under the pharmacodynamic curve of 2 microglobulin; | — |
Secondary
| Measure | Time frame |
|---|---|
| The area under the serum concentration time curve from 0 to infinity;Time of the first appearance of Cmax (Tmax);Safety assessment (physical examination);Safety assessment electrocardiogram;Safety evaluation (adverse events);Safety assessment (vital signs);Safety evaluation (local tolerance at injection site); | — |
Countries
China
Contacts
Public ContactZhong Hui
Nanning First People's Hospital
Outcome results
None listed