Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers

Antiplatelet Drug Clinical Trial

Official title:

Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04404790
• Other study ID #: ZK-APT-201803
• Status: Suspended
• Phase: Phase 1
• Start date: September 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antiplatelet Drug

Intervention

Drug:
• Anfibatide 5 IU/60kg
5 IU/60kg IV administration of Anfibatide with 5 minutes
• Anfibatide 5 IU/60kg +0.002 IU/kg/h
5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
• Anfibatide 5 IU/60kg +0.004 IU/kg/h
5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
• Anfibatide 5 IU/60kg +0.008 IU/kg/h
5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours
• Anfibatide 7 IU/60kg
7 IU/60kg IV administration of Anfibatide with 5 minutes
• Anfibatide 7 IU/60kg +0.002 IU/kg/h
7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
• Anfibatide 7 IU/60kg +0.004 IU/kg/h
7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
• Anfibatide 7 IU/60kg +0.008 IU/kg/h
7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours

Locations

Country	Name	City	State
China	Bengbu Medical College First Hospital	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding events	Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.	7 days after drug administration
Secondary	Cmax	Peak concentration	7 days after drug administration
Secondary	Tmax	Peak time	7 days after drug administration
Secondary	AUC(0-t)	Area under curve 0-t	7 days after drug administration
Secondary	AUC(0-8)	Area under curve 0-8	7 days after drug administration
Secondary	T1/2	Half life	7 days after drug administration
Secondary	Inhibition of platelet aggregation	Inhibition rate of platelet aggregation is measured by chrono-log700.	7 days after drug administration
Secondary	corrected QT interval	Corrected QT interval is measured by 12-lead ECG.	7 days after drug administration