Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers
Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers
This is a phase 1, dose-escalation, and multidose study, aiming to investigate the
 tolerability, safety and pharmacokinetics of Anfibatate in healthy subjects. The study is
 divided into 2 intravenous single groups and 3 continuous administration groups. The dose of
 Anfibatate from 5 IU/60kg to 7 IU/60kg in intravenous single groups. The dose of Anfibatate
 from 0.002 IU/kg/h, 0.004 IU/kg/h to 0.008 IU/kg/h in continuous administration groups.
Inclusion Criteria:

 1. Male or female healthy subjects between the ages of 18 to 40 years（including）.

 2. The body mass index（BMI）， in the range of 19 ~ 24 (including).

 3. Medical history without heart, liver, kidney, digestive tract, nervous system,
 metabolic, ulcer, obvious bleeding, and history of drug allergy or postural
 hypotension.

 4. According to the medical history, physical examination, vital signs, chest radiograph,
 12-lead ECG, coagulation routine, stool routine and occult blood test, as well as the
 laboratory results of blood and urine, the subjects are healthy.

 5. The subjects do not take any medicine in the past two weeks.

 6. Willingness to participate the study and sign the written Informed Consent Form.

 7. Non-lactating women willingness to use adequate contraceptive measures (including
 abstinence, intrauterine device, diaphragm and spermicide) during the study (screening
 period to 1 week after administration). Men are willing to use approved methods of
 contraception (including condoms and spermicides or oral, implanted or injectable
 contraceptives by their partners, intrauterine device, diaphragms and spermicides).
 Subjects do not plan to donate sperm or eggs within two weeks after drug
 administration.

 Exclusion Criteria:

 1. Abnormal with the safety evaluation is considered to be clinical significance in
 screening period as judged by the researcher.

 2. Subjects with history of hepatitis B virus, hepatitis C virus, human immunodeficiency
 virus and syphilis virus infection;

 3. Excessive smoking (>5 cigarettes/day) or do not interrupt smoke during the study.

 4. Intake of more than 25g of alcohol per day (equivalent to 750 mL of beer or 250 mL of
 wine, or 75 mL of white wine of 38 °, or 50 mL of white wine of ≥40 ° ). Subject who
 are positive for alcohol breath test or cannot stop drinking during the study.

 5. Women with pregnant, lactating or menstruating.

 6. History of previous hemoptysis, blood stool, skin mucosal bleeding points, etc., or
 bleeding tendency (patients with gingival, nasal, skin, mucosal bleeding, hemoptysis).

 7. History of active bleeding (peptic ulcer, hemorrhoids, active tuberculosis, subacute
 bacterial endocarditis, etc.).

 8. The examination show arteriovenous malformation, hemangioma and other vascular
 abnormalities.

 9. The examination show that there is hemorrhage in the fundus.

 10. The platelet count is less than 150×109/L.

 11. History of trauma (craniocerebral trauma, etc.) within 1 year.

 12. History of unexplained syncope or convulsions.

 13. History of autoimmune diseases, such as systemic lupus erythematosus.

 14. History of organic or mental illnesses or disabilities.

 15. According to the judgment by the researchers, subjects with low possibility of
 enrollment (such as weak body, etc.).

 16. Donation of blood in the last 3 months or participation in other clinical trials in
 the last 3 months.

 17. Previously recruited into other clinical studies of the product.

 18. Mental, psychological, or language disorders that prevent understanding or
 cooperation.

 19. Unwilling or unable to comply with the study schedule or procedure.

 20. Unfit to participate in the study for any other reason.