stroke
Conditions
Interventions
Test drug group:Recombinant Neutrophil inhibitory factor and Hirul
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects, aged from 18 to 45 years old, male or female; and with a body mass index of 19-26kg/m2, are included in the trial. All subjects are in good health condition examined by medical history, complete physical examination, 12-lead electrocardiograms (ECGs), B ultrasound of upper abdomen, and standard laboratory tests, including standard hematology (red blood cells, leukocytes total and differential, platelets, hemoglobin, and hematocrit), blood chemistry (creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, total protein, albumin, total bilirubin, conjugated bilirubin, unconjugated bilirubin,etc.), cogulation function, platelet aggregation rate, urine analysis, stool rountine test and feacal occult blood. For female subjects of childbearing potential, serum pregnancy test must be negative and agree to use an effective method of contraception till end of the study. T Written informed consent to participate in the study will be obtained from all subjects.
Exclusion criteria
Exclusion criteria: Subjects will be excluded if they have any clinically significant abnormalities at physical examination; any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine and metabolic, immunologic, dermatological, hematologic, neurologic, or psychiatric disease; any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the treatment; and positive serologic findings for HIV antibodies, hepatitis B surface antigen. In addition, any alcohol or drug abuse; allergy or hypersensitivity to the study drug; females with pregnancy and lactation; blood donation within the previous 3 months; participation in another investigational drug study within the previous 3 months; required treatment with medications within 2 weeks of study start; any other ineligible conditions for inclusion into the study according to the investigator’s judgement are excluded from participation. The subjects will understand the objectives and procedures, anticipated effects, and potential adverse reactions of the study, and they have the right to withdraw at any time. Written informed consent to participate in the study will be obtained from all subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerability;pharmacokinetics;pharmacodynamic; | — |
Countries
China
Contacts
Public ContactLi Zheng
West China Hospital, Sichaun University
Outcome results
None listed