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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
5 IU/60kg IV administration of Anfibatide with 5 minutes
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
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
Bengbu Medical College First Hospital
Bengbu, Anhui, China
Bleeding events
Bleeding events are judged according to Bleeding Academic Research Consortium Definition for Bleeding criteria.
Time frame: 7 days after drug administration
Cmax
Peak concentration
Time frame: 7 days after drug administration
Tmax
Peak time
Time frame: 7 days after drug administration
AUC(0-t)
Area under curve 0-t
Time frame: 7 days after drug administration
AUC(0-∞)
Area under curve 0-∞
Time frame: 7 days after drug administration
T1/2
Half life
Time frame: 7 days after drug administration
Inhibition of platelet aggregation
Inhibition rate of platelet aggregation is measured by chrono-log700.
Time frame: 7 days after drug administration
corrected QT interval
Corrected QT interval is measured by 12-lead ECG.
Time frame: 7 days after drug administration
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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
7 IU/60kg IV administration of Anfibatide with 5 minutes
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
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
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