The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
AUC0-inf: area under the concentration-time curve from time zero to infinity
Time frame: 43 days
AUC0-t: area under the concentration-time curve from time zero to the last non-zero concentration
Time frame: 43 days
Cmax: maximum observed concentration
Time frame: 43 days
Tmax: time of observed Cmax
Time frame: 43 days
Kel: apparent terminal elimination rate constant
Time frame: 43 days
T½ el: apparent terminal half-life
Time frame: 43 days
CL: apparent body clearance, calculated as Dose/AUC0-inf
Time frame: 43 days
Vd: apparent volume of distribution, calculated as Dose/(kel x AUC0-inf)
Time frame: 43 days
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