Asthma
Conditions
Interventions
Treatment group:Subcutaneous injection of HS632
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Those who have signed the informed consent and are able to complete the experiment according to the plan; 2. Aged 18 to 40 years(subject to the date of signing the informed consent), male; 3. Body mass index (BMI) between 20 and 26 kg/m2 (including 20 kg/m2 and 26 kg/m2) and body weight between 50 and 75 kg Between 50 kg and 75 kg; 4. Subjects (including partners) voluntarily take effective contraceptive measures, such as abstinence, oral contraceptives, intrauterine devices or double barrier methods (such as condoms and diaphragms), etc.
Exclusion criteria
Exclusion criteria: 1. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor diseases, blood, endocrine, nervous system diseases, or patients with any previous immune diseases (consultation and examination); 2. Severe bleeding factors affecting venous blood collection (consultation and examination); 3. People with skin diseases or other diseases that affect subcutaneous injection (consultation and examination); 4. Screening upper respiratory tract infection or other acute infections within the previous 2 weeks (consultation); 5. Patients with a history of malignant tumor (for consultation); 6. Patients who had undergone surgery within two months prior to signing the informed consent (for consultation); 7. Those who had consumed 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 who had a positive alcohol breath test (consultation, examination) within the previous 6 months were screened; 8. Those who have used soft drugs (e.g., cannabis) or hard drugs (e.g., cocaine, phenylhexidine, etc.) within 3 months before signing the informed consent (consultation);Positive drug abuse test results (morphine, methylamphetamine, ketamine, dimethyldimethoxyamphetamine, tetrahydrocannabinolic acid, cocaine) (test); 9. The average daily smoking quantity in the three months before signing the informed consent was more than 5 cigarettes;Or smoking screening results are positive (consultation, examination); 10. Have a history of drug or food allergy, or have special dietary requirements, and cannot follow the uniform diet;Or a history of specific allergic reactions (asthma, urticaria, eczematous dermatitis, etc.);Or allergic rhinitis;Or known allergy to any component of the drug under test or to latex (contained in the syringe cap) (consultation); 11. Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day (consultation); 12. Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, Chinese patent medicines, vitamins, dietary supplements, etc.) or health care products within 14 days before signing the informed consent (consultation); 13. Chinese medicine (except Chinese patent medicine) and health care products (consultation) are planned to be used during the study; 14. Blood donation history within 3 months prior to signing the informed consent, or planned blood donors during the trial (consultation); 15. Those who plan to receive any biological drug within 3 months after the administration of the experimental drug or monoclonal antibody within 9 months after the administration of the experimental drug (consultation); 16. Planning to donate sperm within 6 months after the administration of the experimental drug (consultation); 17. Those who plan to undergo surgery (including cosmetic surgery, dental surgery and oral surgery) during the study period (consultation); 18. Those who plan to participate in strenuous exercise, including contact exercise or collision exercise (consultation); 19. Participated in other clinical trials within 90 days before signing the informed consent (consultation); 20. Have received any vaccine within 6 months prior to signing the informed consent (consultation); 21. Abnormal subjects considered clinically significant by the researcher during the screening period or the baseline period;Or the followin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration time curve from 0 toinfinity (AUC0-8) ;Peak plasma concentration (*Cmax); | — |
Countries
China
Contacts
Public ContactYang Zhongqi
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed