Asthma
Conditions
Interventions
experimental group:Subcutaneous injection of HS632
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who signed the informed consent and were able to complete the test according to the scheme; 2. Subjects aged >= 18 and <= 40 (subject to the date of signing the informed consent), male; 3. Subjects with body mass index (BMI) between 20-26 kg / m2 (including 20 kg / m2 and 26 kg / m2) and weight between 50-75 kg (including 50 kg and 75 kg); 4. Subjects or their spouses using appropriate and effective contraceptive measures during the trial period, such as abstinence, oral contraceptives, intrauterine devices or double barrier method (such as condom plus contraceptive diaphragm), etc..
Exclusion criteria
Exclusion criteria: 1. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor, blood, endocrine, nervous and other system diseases, or patients with any previous immune diseases; 2. Patients with severe bleeding factors affecting venous blood collection 3. With Skin diseases or other diseases affecting subcutaneous injection; 4. Patients with upper respiratory tract infection or other acute infection in the 2 weeks prior to screening; 5. Patients with history of malignant tumor; 6. Those who have undergone surgery within two months before signing the informed consent; 7. Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol or 2100 ml wine), or whose alcohol breath test is positive; 8. Those who have used soft drugs (e.g., marijuana) within 3 months prior to signing the informed consent or hard drugs (e.g., cocaine, phencyclidine, etc.) within 1 year prior to the trial those who have positive drug abuse test results (morphine, methamphetamine, ketamine, dimethyldioxolamphetamine, tetrahydrocannabinolic acid, cocaine); 9. Those who are addicted to smoking or smoke more than 5 cigarettes per day on average in the 3 months before signing the informed consent; or those who have positive nicotine results; 10. Those who have a history of drug or food allergy, or who have special requirements for diet and cannot abide by the unified diet or specific allergy history (asthma, urticaria, eczema dermatitis, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover); 11. Those who drinking too much tea, coffee and / or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) every day; 12. Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Traditional Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 14 days before signing the informed consent; 13. Traditional Chinese medicine (except proprietary Chinese Medicine) and health care products are planned to be used during the test; 14. Have a blood donation history within 3 months before signing the informed consent, or plan to donate blood during the trial; 15. Those who plan to accept any biological drugs within 3 months after the administration of the test drug or those who plan to accept monoclonal antibody drugs within 9 months; 16. Those who plan to donate sperm within 6 months after the administration of the test drug; 17. Those who plan to undergo (including cosmetic surgery, dental surgery and oral surgery) during the trial period; 18. Those who plan to take part in strenuous exercise during the experiment, including physical contact exercise or collision exercise; 19. Anti-drug antibody (ADA) test is positive; 20. Participants in other clinical trials within 3 months before signing the informed consent; 21. Vaccinated within 6 months before signing the informed consent; 22. Subjects with abnormal clinical significance in physical examination and laboratory examination in screening perio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence of HS632 and Xolair in single subcutaneous administration in healthy subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of HS632 and Xolair in single subcutaneous administration in healthy subjects;Safety of HS632 and Xolair in single subcutaneous administration healthy subjects;Immunogenicity of HS632 and Xolair in single subcutaneous administration in healthy subjects; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed