The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
109
Samsung Investigational Site
Berlin, Germany
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time frame: 57 days
Maximum Serum Concentration (Cmax)
Time frame: 57 days
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time frame: 57 days
Time to Cmax (Tmax)
Time frame: 57 days
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