This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
72
CMAB809 will be administered by IV infusion at a single dose of 6mg/kg.
Trastuzumab will be administered by IV infusion at a single dose of 6mg/kg.
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, China
Area under the concentration-time curve [AUC]
Area under the concentration-time curve \[AUC\] from 0 to the last time point selected of CMAB809
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Cmax
Maximum Serum Concentration(Cmax) of CMAB809
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
AUC0-∞
Area under the concentration-time curve from 0 to inf(AUC0-∞) of CMAB809
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Tmax
The time of maximum blood concentration after administration(Tmax) of CMAB809
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
CL
Total clearance after bioavailability correction(CL) of CMAB809
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
T1/2
Half-life(T1/2) of CMAB809
Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose
Vd
Apparent volume of distribution corrected for bioavailability(Vd) of CMAB809
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Time frame: pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose