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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404790
Recruitment Status : Suspended (Optimization of protocol)
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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.

Condition or disease Intervention/treatment Phase
Antiplatelet Drug Drug: Anfibatide 5 IU/60kg Drug: Anfibatide 5 IU/60kg +0.002 IU/kg/h Drug: Anfibatide 5 IU/60kg +0.004 IU/kg/h Drug: Anfibatide 5 IU/60kg +0.008 IU/kg/h Drug: Anfibatide 7 IU/60kg Drug: Anfibatide 7 IU/60kg +0.002 IU/kg/h Drug: Anfibatide 7 IU/60kg +0.004 IU/kg/h Drug: Anfibatide 7 IU/60kg +0.008 IU/kg/h Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: Anfibatide 5 IU/60kg
Ten subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes.
Drug: Anfibatide 5 IU/60kg
5 IU/60kg IV administration of Anfibatide with 5 minutes

Experimental: Anfibatide 5 IU/60kg+0.002 IU/kg/h
Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.
Drug: 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

Experimental: Anfibatide 5 IU/60kg+0.004 IU/kg/h
Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.
Drug: 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

Experimental: Anfibatide 5 IU/60kg+0.008 IU/kg/h
Four or fourteen subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.
Drug: 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

Experimental: Anfibatide 7 IU/60kg
Ten subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes.
Drug: Anfibatide 7 IU/60kg
7 IU/60kg IV administration of Anfibatide with 5 minutes

Experimental: Anfibatide 7 IU/60kg+0.002 IU/kg/h
Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours.
Drug: 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

Experimental: Anfibatide 7 IU/60kg+0.004 IU/kg/h
Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours.
Drug: 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

Experimental: Anfibatide 7 IU/60kg+0.008 IU/kg/h
Four or fourteen subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours.
Drug: 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




Primary Outcome Measures :
  1. Bleeding events [ Time Frame: 7 days after drug administration ]
    Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 7 days after drug administration ]
    Peak concentration

  2. Tmax [ Time Frame: 7 days after drug administration ]
    Peak time

  3. AUC(0-t) [ Time Frame: 7 days after drug administration ]
    Area under curve 0-t

  4. AUC(0-∞) [ Time Frame: 7 days after drug administration ]
    Area under curve 0-∞

  5. T1/2 [ Time Frame: 7 days after drug administration ]
    Half life

  6. Inhibition of platelet aggregation [ Time Frame: 7 days after drug administration ]
    Inhibition rate of platelet aggregation is measured by chrono-log700.

  7. corrected QT interval [ Time Frame: 7 days after drug administration ]
    Corrected QT interval is measured by 12-lead ECG.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404790


Locations
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China, Anhui
Bengbu Medical College First Hospital
Bengbu, Anhui, China, 233004
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
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Study Director: Ningru Zhang Bengbu Medical College First Hospital
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT04404790    
Other Study ID Numbers: ZK-APT-201803
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No