Acute ischemic stroke
Conditions
Interventions
Single dose 5mg dose group:Y-3 injection
All other dose groups except single dose 5mg dose group:Y-3 injection / Y-3 blank injection
Sponsors
Liuzhou workers hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy adult male and female subjects, aged between 18 and 45 years, including both ends; 2. Male weight >= 50kg, female weight >= 45kg, body mass index (BMI) between 19 and 26kg/m2, including both ends; 3. Subjects who can understand and sign the informed consent form before any test related procedures.
Exclusion criteria
Exclusion criteria: 1. Clarify the past allergy to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodium hydroxide); 2. Those who have suffered or are currently suffering from any clinical serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities, and have been determined by the researchers to have clinical significance; 3. Abnormal ECG or vital signs, which are judged by the research doctor to be clinically significant; 4. Those found abnormal in laboratory tests (blood routine, urine routine, coagulation function, blood biochemical tests, etc.) and other screening tests and judged by the researcher to be of clinical significance; 5. People with positive HIV antibody test, positive Treponema pallidum specific antibody test, positive hepatitis B surface antigen test or positive hepatitis C antibody test; 6. Alcoholics or regular drinkers within 6 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit=360 mL of beer or 45 mL of alcohol with 40% alcohol content or 150 mL of wine), or whose alcohol breath test results are greater than 0.0mg/100mL, or who cannot abstain from alcohol during the test; 7. Those who smoke more than 3 cigarettes per day on average in the three months before screening or who cannot give up smoking during the whole test period; 8. Have a history of drug abuse, drug dependence or drug abuse screening positive; 9. Those who are allergic to any food or medicine or have special requirements for diet and cannot follow the unified diet; 10. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups) every day three months before screening or take special diet (including pitaya, mango, grapefruit, etc.) within two weeks before screening; 11. Those who have taken any prescription drugs or non-prescription drugs, traditional Chinese medicine or Chinese herbal medicine, health care products within 14 days before screening, or have received vaccination within 14 days before screening; Or planned to be vaccinated during the trial; 12. Those who participated in any other drug clinical trial as subjects within 3 months before screening; 13. Those who donated blood or lost more than 200ml of blood three months before screening; 14. Have unprotected sex (female), or women during pregnancy or lactation, within 14 days before screening or after screening and before check-in; 15. Male subjects (or their partners) or female subjects have family planning during the whole trial period and within 3 months after the end of the study, or the subjects are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, ligation, etc.) during the trial period; 16. The researcher believes that other reasons are not suitable for enrollment or the subjects voluntarily withdraw from the test due to their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax?AUC0-t?AUC0-8?Tmax?t1/2??z?AUC_%Extrap?Vz?CL?MRT0-t?MRT0-8;;Cav, ss?Cmax, ss?Cmin, ss?AUCt?AUC0-t, ss?AUC0-8, ss?DF?Tmax, ss?t1/2, ss?CLss?Vz, ss??z?AUC_%Extrap?Ra(AUC)?Ra(Cmax);Vital signs monitoring, physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), blood / urine pregnancy, ECG, etc; | — |
Countries
China
Contacts
Public ContactHua Yao
neurodawn
Outcome results
None listed