NCT04404790

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 26, 2020

Last Update Submit

May 26, 2020

Conditions

Antiplatelet Drug

Outcome Measures

Primary Outcomes (1)

  • Bleeding events

    Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.

    7 days after drug administration

Secondary Outcomes (7)

  • Cmax

    7 days after drug administration

  • Tmax

    7 days after drug administration

  • AUC(0-t)

    7 days after drug administration

  • AUC(0-∞)

    7 days after drug administration

  • T1/2

    7 days after drug administration

  • +2 more secondary outcomes

Study Arms (8)

Anfibatide 5 IU/60kg

EXPERIMENTAL

Ten subjects will injected with the dose of 5 IU/60kg of Anfibatide with 5 minutes.

Drug: Anfibatide 5 IU/60kg

Anfibatide 5 IU/60kg+0.002 IU/kg/h

EXPERIMENTAL

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

Anfibatide 5 IU/60kg+0.004 IU/kg/h

EXPERIMENTAL

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

Anfibatide 5 IU/60kg+0.008 IU/kg/h

EXPERIMENTAL

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

Anfibatide 7 IU/60kg

EXPERIMENTAL

Ten subjects will injected with the dose of 7 IU/60kg of Anfibatide with 5 minutes.

Drug: Anfibatide 7 IU/60kg

Anfibatide 7 IU/60kg+0.002 IU/kg/h

EXPERIMENTAL

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

Anfibatide 7 IU/60kg+0.004 IU/kg/h

EXPERIMENTAL

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

Anfibatide 7 IU/60kg+0.008 IU/kg/h

EXPERIMENTAL

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

Interventions

Anfibatide 5 IU/60kgDRUG

5 IU/60kg IV administration of Anfibatide with 5 minutes

Anfibatide 5 IU/60kg
Anfibatide 5 IU/60kg +0.002 IU/kg/hDRUG

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+0.002 IU/kg/h
Anfibatide 5 IU/60kg +0.004 IU/kg/hDRUG

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+0.004 IU/kg/h
Anfibatide 5 IU/60kg +0.008 IU/kg/hDRUG

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 5 IU/60kg+0.008 IU/kg/h
Anfibatide 7 IU/60kgDRUG

7 IU/60kg IV administration of Anfibatide with 5 minutes

Anfibatide 7 IU/60kg
Anfibatide 7 IU/60kg +0.002 IU/kg/hDRUG

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+0.002 IU/kg/h
Anfibatide 7 IU/60kg +0.004 IU/kg/hDRUG

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+0.004 IU/kg/h
Anfibatide 7 IU/60kg +0.008 IU/kg/hDRUG

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

Anfibatide 7 IU/60kg+0.008 IU/kg/h

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female healthy subjects between the ages of 18 to 40 years（including）.
  • The body mass index（BMI）， in the range of 19 \~ 24 (including).
  • Medical history without heart, liver, kidney, digestive tract, nervous system, metabolic, ulcer, obvious bleeding, and history of drug allergy or postural hypotension.
  • 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.
  • The subjects do not take any medicine in the past two weeks.
  • Willingness to participate the study and sign the written Informed Consent Form.
  • 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.

You may not qualify if:

  • Abnormal with the safety evaluation is considered to be clinical significance in screening period as judged by the researcher.
  • Subjects with history of hepatitis B virus, hepatitis C virus, human immunodeficiency virus and syphilis virus infection;
  • Excessive smoking (\>5 cigarettes/day) or do not interrupt smoke during the study.
  • 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.
  • Women with pregnant, lactating or menstruating.
  • History of previous hemoptysis, blood stool, skin mucosal bleeding points, etc., or bleeding tendency (patients with gingival, nasal, skin, mucosal bleeding, hemoptysis).
  • History of active bleeding (peptic ulcer, hemorrhoids, active tuberculosis, subacute bacterial endocarditis, etc.).
  • The examination show arteriovenous malformation, hemangioma and other vascular abnormalities.
  • The examination show that there is hemorrhage in the fundus.
  • The platelet count is less than 150×109/L.
  • History of trauma (craniocerebral trauma, etc.) within 1 year.
  • History of unexplained syncope or convulsions.
  • History of autoimmune diseases, such as systemic lupus erythematosus.
  • History of organic or mental illnesses or disabilities.
  • According to the judgment by the researchers, subjects with low possibility of enrollment (such as weak body, etc.).
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bengbu Medical College First Hospital

Bengbu, Anhui, 233004, China

Location

MeSH Terms

Interventions

agkisacucetin protein, Agkistrodon acutus

Study Officials

  • Ningru Zhang

    Bengbu Medical College First Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2020

First Posted

May 28, 2020

Study Start

September 1, 2020

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

CN(1)