The purpose of this study is to evaluate the pharmacokinetic similarity of bevacizumab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of bevacizumab with different manufacturing process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
100
3mg/kg,I.V.,single dose
3mg/kg,I.V.,single dose
The first affiliated hospital of Soochow university
Suzhou, Jiangsu, China
Primary Outcome Measure:Area Under the Curve(AUC0-∞)
Time frame: 84days
Area Under the Curve(AUClast)
Time frame: 84days
Maximum Concentration (Cmax)
Time frame: 84days
Volume of distribution (V)
Time frame: 84days
Total body clearance (CL)
Time frame: 84days
Elimination half-life (t1/2)
Time frame: 84days
Time at which maximum concentration occurred (Tmax)
Time frame: 2016days
Incicende of Adverse Events (AEs)
Time frame: 98days
Anti-drug Antibody(ADA)and Neutralizing Antibody(NAb)
Time frame: 98days
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