drugset / Trial / NCT01865552

Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects

NCT01865552

Phase 1 Completed 138 enrolled Samsung Bioepis Co., Ltd.
RandomizedCrossoverSingle-blindOther

Summary

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.

Timeline

Start
2013-05
Primary completion
2013-08
Completion
2013-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic Subcutaneous
Subject SB4 Protein / enzyme biologic Subcutaneous

Indications

No indication recorded.