Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Summary

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.

Timeline

Start

2014-02

Primary completion

2014-04

Completion

2014-04

Publications

• Pivot X, Curtit E, Lee YJ, Golor G, Gauliard A, Shin D, Kim Y, Kim H, Fuhr R. A Randomized Phase I Pharmacokinetic Study Comparing Biosimilar Candidate SB3 and Trastuzumab in Healthy Male Subjects. Clin Ther. 2016 Jul;38(7):1665-1673.e3. doi: 10.1016/j.clinthera.2016.06.002. Epub 2016 Jun 29.

Drugs

Indications

No indication recorded.