Thrombotic diseases
Conditions
Interventions
0.20mg/kg dose:single dose of r-RGD-hirudin injection administered subcutaneously(10 sujects)
single dose of sterile water for injection administered subcutaneously (2 subjects)
0.30mg/kg dose:single dose of r-RGD-hirudin injection administered subcutaneously(10 sujects)
0.40mg/kg dose:single dose of r-RGD-hirudin injection administered subcutaneously(10 sujects)
0.50mg/kg dose:single dose of r-RGD-hirudin injection administered subcutaneously(10 sujects)
0.60mg/kg dose:single dose of r-RGD-hirudin injection administered subcutaneously(10 sujects)
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), Doppler ultrasound of upper abdomen, and clinical 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. Subjects will be capable of giving written informed consents voluntarily, and agree to comply with the requirements of clinical protocols.
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; a history of abnomal bleeding within the previous 3 months; platelets <100000/mm3; 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 (HBsAg), and HCV(hepatitis C virus) antibody. In addition, any alcohol or drug abuse; allergy or hypersensitivity to the study drug; females with pregnancy and lactation and menstrual phase; 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 investigators judgement are excluded from participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety (monitoring of adverse events (AEs), physical examination, vital signs, clinical laboratory tests and 12-lead electrocardiograms (ECGs), etc);pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| phamacodynamics(cogulation variables(APTT, TT,etc.); platelet aggregation rate); | — |
Countries
China
Contacts
Public ContactZhongping Gou
Institue of National Drug Clinical Trail/GCP center, West China Hospital, Sichuan University
Outcome results
None listed