Clinical trial NCT04404790: Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers
Official title: Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Antiplatelet Drug
Lead sponsor: Lee's Pharmaceutical Limited
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bleeding events
timeFrame: 7 days after drug administration
Secondary outcomes:
measure: Cmax
timeFrame: 7 days after drug administration
measure: Tmax
timeFrame: 7 days after drug administration
measure: AUC(0-t)
timeFrame: 7 days after drug administration
measure: AUC(0-∞)
timeFrame: 7 days after drug administration
measure: T1/2
timeFrame: 7 days after drug administration
measure: Inhibition of platelet aggregation
timeFrame: 7 days after drug administration
measure: corrected QT interval
timeFrame: 7 days after drug administration
Other outcomes:
Locations:
city: Bengbu
country: China
facility: Bengbu Medical College First Hospital
state: Anhui
Study officials:
affiliation: Bengbu Medical College First Hospital
name: Ningru Zhang
role: STUDY_DIRECTOR
References: