Acute ischemic stroke
Conditions
Interventions
RT group:Subjects were infused intravenously with 40 mg of Y-3 injection according to the appropriate dosing sequence, which was administered once in the first cycle of the trial, with a washout perio
TR group:Subjects were infused intravenously with 40 mg of injectable Y-3 according to the appropriate dosing sequence, with one administration in the first cycle of the trial, a washout period of 7 d
Sponsors
Liuzhou Workers' Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled: 1) Healthy adult male and female subjects, aged between 18 and 45 years including both end values; 2) Males weighing =50 kg and females weighing =45 kg with a body mass index (BMI) between 19 and 26 kg/m^2 including values at both ends of the spectrum; 3) Subjects who are able to understand and voluntarily sign an informed consent form prior to any trial-related procedures.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded: 1)Definite prior hypersensitivity to this product or any of its excipients (polyethylene glycol 15-hydroxystearate, propylene glycol, sodium hydroxide, mannitol, potassium dihydrogen phosphate, dipotassium hydrogen phosphate trihydrate); 2)Previous or current suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities that are judged to be clinically significant by the investigator; 3)Abnormal electrocardiogram or abnormal vital signs that are judged by the investigator to be clinically significant, laboratory tests (routine blood, urine, coagulation, blood biochemistry tests, etc.) and other screening tests that reveal abnormalities that are judged by the investigator to be clinically significant; 4)Those who test positive for human immunodeficiency virus antibody, positive for syphilis spirochete-specific antibody, positive for hepatitis B surface antigen, or positive for hepatitis C antibody; 5)Alcoholics or those who have regularly consumed alcohol in the 6 months prior to screening, i.e., an average of more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits of 40% alcohol by volume or 150 mL of wine) or an alcohol breath test result of greater than 0.0 mg/100mL, or those who are unable to abstain from alcohol for the duration of the test; 6) Those who smoked an average of more than 5 cigarettes per day in the 3 months prior to screening or who were unable to abstain from smoking for the entire duration of the trial; 7) Anyone with a history of substance abuse, drug dependence, or a positive screen for substance abuse; 8) Any food or drug allergy or special dietary requirements that prevent compliance with a uniform diet; 9)Anyone who has consumed excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup ˜ 250 mL) per day in the 3 months prior to screening or who has taken a special diet (including dragon fruit, mango, grapefruit, etc.) in the 2 weeks prior to screening; 10)Those who have taken any prescription or over-the-counter medications, Chinese or herbal medicines, or health supplements within 14 days prior to screening, or those who have been vaccinated within 14 days prior to screening; or those who plan to be vaccinated during the trial; 11) Those who have participated as a subject in any other drug clinical trial within 3 months prior to screening; 12) who have donated or lost blood greater than or equal to 200 mL within 3 months prior to screening; or who plan to donate blood during the trial; 13)Those who have had unprotected sex within 14 days prior to screening or after screening until admission (females), or those who are pregnant or lactating; 14) Male subjects (or their partners) or female subjects who plan to have children throughout the trial and for 90 days after discharge from the group or subjects who are unwilling to use one or more non-pharmacological contraceptive methods (e.g., total abstinence, condoms, ligation, etc.) during the trial; 15) Other reasons deemed by the investigator to be unsuitable for enrollment or subjects who withdrew from the trial on their own initiative for their own reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;?z;AUC_%Extrap;Vz;CL;MRT0-t;MRT0-8;vital signs monitoring;physical examination;blood routine;blood biochemistry;urine routine;coagulation function;ECG;clinical symptom;adverse event;adverse reaction; | — |
Countries
China
Contacts
Public ContactYazhou Wang
Liuzhou Workers' Hospital
Outcome results
None listed