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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

Tracking Information
First Submitted Date  ICMJE May 26, 2020
First Posted Date  ICMJE May 28, 2020
Last Update Posted Date May 28, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
Bleeding events [ Time Frame: 7 days after drug administration ]
Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Cmax [ Time Frame: 7 days after drug administration ]
    Peak concentration
  • Tmax [ Time Frame: 7 days after drug administration ]
    Peak time
  • AUC(0-t) [ Time Frame: 7 days after drug administration ]
    Area under curve 0-t
  • AUC(0-∞) [ Time Frame: 7 days after drug administration ]
    Area under curve 0-∞
  • T1/2 [ Time Frame: 7 days after drug administration ]
    Half life
  • Inhibition of platelet aggregation [ Time Frame: 7 days after drug administration ]
    Inhibition rate of platelet aggregation is measured by chrono-log700.
  • corrected QT interval [ Time Frame: 7 days after drug administration ]
    Corrected QT interval is measured by 12-lead ECG.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiplatelet Thrombolysin (Anfibatide) Phase 1 Clinical Trial in Healthy Volunteers
Official Title  ICMJE Phase I Clinical Trial of the Tolerance and Pharmacokinetics of Anfibatide in Health Volunteer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Antiplatelet Drug
Intervention  ICMJE
  • Drug: Anfibatide 5 IU/60kg
    5 IU/60kg IV administration of Anfibatide with 5 minutes
  • 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
  • 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
  • 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
  • Drug: Anfibatide 7 IU/60kg
    7 IU/60kg IV administration of Anfibatide with 5 minutes
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Anfibatide 5 IU/60kg
    Ten subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes.
    Intervention: Drug: Anfibatide 5 IU/60kg
  • 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.
    Intervention: Drug: Anfibatide 5 IU/60kg +0.002 IU/kg/h
  • 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.
    Intervention: Drug: Anfibatide 5 IU/60kg +0.004 IU/kg/h
  • 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.
    Intervention: Drug: Anfibatide 5 IU/60kg +0.008 IU/kg/h
  • Experimental: Anfibatide 7 IU/60kg
    Ten subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes.
    Intervention: Drug: Anfibatide 7 IU/60kg
  • 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.
    Intervention: Drug: Anfibatide 7 IU/60kg +0.002 IU/kg/h
  • 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.
    Intervention: Drug: Anfibatide 7 IU/60kg +0.004 IU/kg/h
  • 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.
    Intervention: Drug: Anfibatide 7 IU/60kg +0.008 IU/kg/h
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 26, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04404790
Other Study ID Numbers  ICMJE ZK-APT-201803
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lee's Pharmaceutical Limited
Study Sponsor  ICMJE Lee's Pharmaceutical Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ningru Zhang Bengbu Medical College First Hospital
PRS Account Lee's Pharmaceutical Limited
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP