Acute Ischemic Stroke
Conditions
Interventions
Single dose - placebo -25mg group:25mg placebo, administered as a single intravenous drip
Single administration of -AAPB-75mg group:75mg AAPB for injection.The drug was administered as a single intravenous drip
Single dose - placebo -10mg group:10mg placebo, administered as a single intravenous drip
Single administration of -AAPB-25mg group:25mg AAPB for injection.The drug was administered as a single intravenous drip
Single dose - placebo -75mg group:75mg of placebo was administered as a single intravenous infusion
Single administration of -AAPB-50mg group:50mg AAPB for injection.The drug was administered as a single intravenous drip
Multiple administration-AAPB-B group for injection :AAPB-B group dose for injection An intravenous drip. Once a day for 7 days
Single dose - placebo -100mg group:100mg of placebo was administered as a single intravenous infusion
Single administration of -AAPB-100mg group:100mg AAPB for injection.The drug was administered as a single intravenous drip
Single dose - placebo -50mg group:50mg of placebo was administered as a single intravenous infusion
Multiple dosing -Placebo-B group:Placebo, Group B dose, Intravenous infusion, Once a day for 7 days
Multiple dosing -Placebo-A group:Placebo, Group A dose, Intravenous infusion, Once a day for 7 days
Sponsors
Beijing Tiantan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Healthy subjects 18 years old = age =45 years old male and female; (2) At the time of screening body weight was =50kg for men and =45kg for women with body mass index (BMI) in the range of 19-28 kg/m^2 (including upper and lower limits) BMI= weight (kg)/height (m) ^2; (3) able to communicate well with the investigators willing and able to abide by the lifestyle restrictions specified in the protocol; (4) a woman or man of reproductive age who consented to use a contraceptive method approved by the investigator (e.g. intrauterine device condom spermicidal gel plus condom or uterine cap) throughout the trial; (5) Fully understand the purpose and requirements of the trial voluntarily participate in the clinical trial and sign the written informed consent and be able to complete all the trial process according to the requirements of the trial.
Exclusion criteria
Exclusion criteria: (1) The subject's history of present illness and previous diseases or dysfunction that may affect the clinical trial as determined by the investigator including but not limited to diseases of the nervous system cardiovascular system respiratory system digestive system urinary system endocrine system metabolic disease rheumatic disease blood system and other diseases; (2) patients with mental illness or previous history of mental illness; (3) patients with a history of malignant tumor or other diseases ineligible for clinical trial participation; (4) History of cardiovascular disease (such as heart failure coronary artery disease cardiomyopathy valvular heart disease or family history of congenital long QT syndrome or sudden death) or electrocardiogram results: QTcF > 450ms or clinically significant conduction block or T wave change; (5) abnormal liver function (ALT AST higher than the upper limit of normal reference value); (6) use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g. barbiturates carbamazepine phenytoin glucocorticoids omeprazole etc.) within 30 days before the study drug administration; Inhibitors 5-hydroxytryptamine reuptake inhibitors (SSris) antidepressants cimetidine diltiazem macrolides nitroimidazole sedative hypnotics verapamil fluoroquinolones antihistamines etc.); Or taking any prescription over-the-counter and herbal medicines other than those listed above within 14 days before administration of the study drug; (7) participated in any clinical trial within 3 months before enrollment; (8) those who have special requirements for food and cannot follow a uniform diet; (9) those who consumed any caffeine-rich food or beverage (coffee tea cola chocolate etc.) within 48 h before the study drug administration or who did not agree to prohibit the use of any caffeine-rich food or beverage during the study; (10) patients with known history of allergy to test drug components or similar drugs history of allergic diseases or allergic constitution; (11) smokers who smoked more than 10 cigarettes per day in the previous year or disobedient to the ban on smoking during the study period; (12) Heavy drinkers with an average weekly alcohol intake of more than 14 units (1 unit =285ml beer or 25ml spirits or 150ml wine) in the previous year or with a positive alcohol breath test; (13) patients with drug abuse history within 1 year before screening or with positive screening results for drug abuse (screening tests included morphine THC methamphetamine dimethylenedioxyamphetamine ketamine and cocaine); (14) if the comprehensive physical examination vital signs laboratory tests and ECG were judged by the investigators to be abnormal and clinically significant; (15) Hepatitis B surface antigen (HBsAg) hepatitis C antibody (HCV-Ab) HIV antibody (HIV-Ab) treponema pallidum antibody (TP-Ab) positive; (16) pregnant or lactating women or with a positive serum HCG test before trial administration or unable or unwilling to follow the instructions of the investigators to use contraceptive methods approved by the investigators during the study and within 3 months after the end of the study; (17) blood donation or blood loss =200ml within 3 months before drug administration or use of blood products; (18) had a history of surgery within 3 months before study administration or had not recovered from surgery or had planned surgery during the trial; (19) personnel directly related to the clinical trial; (2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse event;Metabolite M3;S-APB;Cmax;Metabolite M4; | — |
Countries
China
Contacts
Public Contactlishuya
Beijing Tiantan Hospital Capital Medical University
Outcome results
None listed