For the preventive treatment of adult migraine
Conditions
Interventions
Test group:Subcutaneous Injection of HWS111 Injection
Control group:Subcutaneous Injection of Erenumab Injection (trade name: Aimovig)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily participate in this clinical study and sign the informed consent form before participating in the study; 2. The subjects are healthy Chinese male or female subjects aged 18-45 years (including the boundary values); 3. Male subjects must have a body weight of >=50.0 kg, female subjects must have a body weight of>=45.0 kg, and the body mass index (BMI) must be within the range of 18 - 26 kg/m^2 (including the boundary values). BMI = weight (kg) / [height (m)]^2; 4. The subjects (including their partners) agree that from 2 weeks before the screening date to 6 months after receiving the trial drug, they have no plans for pregnancy or sperm donation, and voluntarily take effective contraceptive measures (see Appendix 3 for details); 5. The subjects can communicate well with the researchers, understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Those with clinically significant gastrointestinal diseases, kidney diseases, liver diseases, cardiovascular diseases, hematological diseases, pulmonary diseases, neurological diseases, metabolic diseases, mental illnesses, allergic diseases, and other diseases that the researcher deems unsuitable for participation in this clinical study; 2. Those with abnormal results in vital signs, physical examinations, laboratory tests, or electrocardiogram examinations, and which are judged by the researcher to be clinically significant; 3. There are chronic or acute infections with clinical significance; 4. History of clinically significant QT interval prolongation, or QTcF > 460ms (female) and > 450ms (male) during the screening period; 5. Those who are positive for hepatitis B virus surface antigen, or positive for hepatitis C virus antibody, or positive for treponema pallidum antibody, or positive for human immunodeficiency virus antibody; 6. Patients with a history of hypersensitivity or allergic reactions to CGRP receptor antagonists, or CGRP antagonists, or any ingredients contained in this product and the natural latex ingredients in the device; 7. Those who have used erenumab injection, or any biological agents within 6 months before screening; 8. Screen those who have had reduced defecation frequency (less than 3 times), difficulty in defecation, or a history of severe constipation within the first 7 days; 9. Screen those who have taken any prescription drugs, over-the-counter drugs, vitamin products, or Chinese herbal medicines within the previous 14 days; 10. Those who have participated in other clinical trials within the previous 3 months or plan to participate in other drug clinical trials during the study period; 11. Exclude those who have donated blood or lost a large amount of blood (>400mL) within the previous 3 months, or plan to donate blood during the study period; 12. Screen those who have been vaccinated within the previous month or plan to be vaccinated during the study period; 13. Those who have undergone any surgical operation within the previous month before screening or plan to undergo a surgical operation during the study period; 14. Screen out those who smoke more than 5 cigarettes per day in the first 3 months, or are unwilling to stop smoking during the trial period; 15. Screen those who consume 14 units of alcohol per week within the first 3 months (1 unit is equal to 17.5mL or 14g of pure alcohol; the alcohol content of different types of alcoholic beverages is indicated by volume ratio; 1 alcohol unit is approximately equal to 35mL of 50-proof baijiu or 350mL of 5-degree beer), or those with positive blood alcohol test results, or those who are unwilling to stop drinking during the trial period; 16. Those who drink excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups per day, with 1 cup = 250mL) every day within the previous 3 months, or those who cannot stop drinking tea, coffee, or caffeinated beverages during the trial period; 17. Screen those with a history of drug abuse within the previous year; 18. Those with a history of postural hypotension, needle phobia, blood phobia, or intolerance to venous puncture for blood collection; 19. Female subjects with clinically significant abnormal pregnancy tests; 20. Those with positive results in drug abuse screening; 21. Researchers believe that there are other situations where individuals are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity assessment;safety outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed