The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
* Part A: Comparison between SB4 and EU sourced Enbrel * Part B: Comparison between SB4 and US sourced Enbrel * Part C: Comparison between EU sourced Enbrel and US sourced Enbrel
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
138
SC administration
SC administration
SC administration
Parexel International GmbH
Berlin, Germany
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time frame: 0 to 480 hours post-dose
Maximum Serum Concentration (Cmax)
pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.
Time frame: 0 to 480 hours post-dose
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time frame: 0 to 480 hours post-dose
Time to Cmax (Tmax)
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Time frame: 0 to 480 hours post-dose
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