Acute Ischemic Stroke,AIS
Conditions
Interventions
SAD: 1.0ml ,3mg/ml F008 . 100ml 0.9%,,0.150.5mg/k 1h(±5min)
1.01.52.0mg/kg 2h(±10min).
MAD:According to the results of the first part of the study, the dosing dose and dosing time of multiple dosing studies were determined.
Give the drug once a day for 5 day
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria to be enrolled in the study: 1) Healthy adult subjects aged 18-45 years (including the critical value), both male and female; 2) Body weight of male subjects =50.0 kg and female subjects =45.0 kg, body weight refers to Number (BMI) between 18 and 28kg/m2, including the critical value, body mass index = body weight (kg)/ Height 2 (m2); 3) The subjects have a good daily routine and can maintain good communication with the researchers Compliance with clinical trial requirements; 4) Participate voluntarily and sign informed consent.
Exclusion criteria
Exclusion criteria: Subjects with any of the following criteria were excluded from the study: 1) Severe heart, lung, liver, kidney, blood, endocrine, immune, skin diseases in the past 5 years Those who have a history of neurological or mental illness or have any of these systemic diseases; 2) a history of clinically significant drug/food allergies or atopic allergic diseases (e.g Asthma, urticaria, eczema dermatitis, etc.) or known to study drug ingredients and excipients A quick person; 3) Abnormal blood routine, blood biochemistry, urine routine, electrocardiogram, coagulation function test and so on Clinical significance; 4) Virological examination of hepatitis B, hepatitis C antibodies, HIV antibodies, treponema pallidum antibodies Positive and clinically significant; 5) Those who are prone to bleeding, such as those who usually cause bleeding or subcutaneous bleeding due to mild collision; 6) Patients with difficulty in venipunction, those who cannot tolerate venipunction, and those who have a history of fainting needles and blood; 7) Had surgery prior to initial dosing or planned to have surgery during the study period This; 8) Those who have taken any medication within 14 days prior to the first dose (including prescription, over-the-counter, Chinese herbal medicine); 9) have been treated with any other investigational drug/device within 3 months prior to the first dose; 10) Blood donation or large blood loss within 3 months before the first dose (=400 ml, female normal physiology (except stage blood loss), receiving blood transfusions or using blood products; 11) Those who have special requirements for diet and cannot comply with a unified diet; 12) Smoking =5 cigarettes per day in the 3 months before the first dose, or unwilling to stop during the trial Use any tobacco products; 13) Positive breath test results for alcohol, or binge drinking within 3 months prior to first dosing (weekly Alcohol over 14 units alcohol: 1 unit = about 285mL for beer, or about 25mL for spirits, Or wine about 100mL); 14) A history of drug abuse within the year prior to first dosing (including repeated, substantial, non-medical use) Use of narcotic drugs and psychotropic substances) or test positive for drug abuse; 15) Received inactivated vaccine within 1 month before the first dose and within 3 months before the first dose Receive live/attenuated vaccination or plan to receive any vaccination during the trial This; 16) Pregnant or lactating women and those who were pregnant between the study period and 1 month after the end of the trial Pregnancy plan or sperm donation, egg donation plan, do not want to use a medical approval during the trial Use contraceptives (such as Iuds or condoms); 17) Those who may not be able to complete the study for other reasons or who the researcher believes should not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of TNHH in plasma; Cmax;AUC0-8;AUC0-t;Tmax;t1/2;Cmax,ss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmin,ss;?z; | — |
Countries
China
Contacts
Public ContactQi Shen
West China Hospital of Sichuan University
Outcome results
None listed