Acute ischemic stroke
Conditions
Interventions
Experimental group:Inject YZD-27 90mg intravenously daily for 7 consecutive days, with one dose on the 7th day. Observe the safety, tolerability, and pharmacokinetic characteristics of YZD-27.
Placebo group :Daily intravenous injection of placebo was administered for 7 consecutive days, with one dose on the 7th day, to compare the safety of YZD-27.
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and provide a signed and dated informed consent form; 2. The age range for screening visits is between 18 and 45 years old (including the threshold), male or female; 3. The weight of male subjects shall not be less than 50 kilograms, and the weight of female subjects shall not be less than 45 kilograms. Body mass index within the range of 19.0 to 26.0 kg/m^2 (including critical values); 4. If the subject is female, they must meet the following criteria: (1). no fertility potential, including subjects who have undergone surgical sterilization (recorded tubal ligation, hysterectomy, or bilateral salpingectomy), and at the screening visit subjects who have experienced menopause or have had continuous amenorrhea for more than 12 months; (2). If there is fertility potential, it must be non pregnant, non lactating, and must agree to use non pharmacological contraceptive measures 14 days before administration, during the study period, and within 6 months after administration, and the human chorionic gonadotropin (hCG) test result must be negative at screening visits and D-1; If it is a male subject and their female partner with fertility, they must agree to take appropriate contraceptive measures 14 days before administration, during the study period, and within 6 months after the last administration. And during this period, participants are not allowed to donate sperm or eggs; 5. Willing to comply with the visit, study treatment, laboratory testing, and other research related procedures and requirements specified in the research protocol.
Exclusion criteria
Exclusion criteria: 1. Allergic to experimental drugs or their excipients, or with a history of severe allergies (including any food or drug allergies); 2. Previous major diseases or physical conditions of the central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal disorders, urinary system, or tumors, or existing acute diseases, or other diseases or physical conditions that the researcher deems may affect the study or pose unacceptable risks to the subjects; 3. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or Treponema pallidum antibody (TP Ab); 4. Resting systolic blood pressure (SBP)>140 or90 or100 or450 ms in males, or>470 ms in females; 7. Screening or baseline serum alanine aminotransferase (ALT) or alanine aminotransferase (AST) levels greater than the upper limit of normal (ULN); 8. The glomerular filtration rate (GFR) calculated based on the CKD-EPI creatinine formula is less than 90 ml/min/1.73 m ^ 2; 9. History of drug abuse (such as morphine, methamphetamine, ketamine, methylenedioxymethamphetamine, tetrahydrocannabinol acid, cocaine, etc.), or positive drug screening test results; 10. Alcoholism within the past year prior to screening (drinking more than 21 standard units of alcohol per week, with one standard unit containing 14 g of alcohol, such as 360 ml of 5% beer, 45 ml of 40% spirits, and 120 ml of 12% wine), or a positive breathalyzer test for alcohol, or failure to comply with the prohibition of alcohol intake from 14 days before administration until 24 hours after the last administration when PK samples are collected; 11. Smoking more than 5 cigarettes per day within the 3 months prior to the screening period, or failing to comply with the regulations prohibiting the use of nicotine containing products from 14 days prior to administration until the last visit; 12. Within 7 days prior to the start of the experiment, consuming food or beverages containing enzymes that can induce or inhibit liver metabolism (such as grapefruit); Disagree or unable to guarantee completion of the trial from 48 hours prior to the first administration During the subsequent pharmacokinetic blood sample collection period, do not consume any food or beverage containing or metabolized to produce caffeine or xanthine (such as coffee, tea, chocolate); 13. Received any vaccine within the 30 days prior to screening, or planned to receive any vaccine during the study period; 14. During the 14 days prior to administration (if the 5 half lives of the medication used exceed 14 days, the 5 half lives shall prevail) until the last visit, it is unavoidable to use any medication, including prescription and over-the-counter drugs (excluding topical eye/nose drops and creams with no systemic exposure risk), vitamins (excluding conventional vitamins), health supplements, and Chinese herbal medicines; 15. Received any investigational drug treatment or participated in any drug/research device trial within 3 months prior to administration; 16. Having undergone major surgical procedures within 30 days prior to administration or planning to undergo major surgical procedures during the study period; 17. Currently pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;12-lead electrocardiogram indicators ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactYang Guoping
The Third Xiangya Hospital of Central South University
Outcome results
None listed