Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects

NCT02453672 ↗

Phase 1 Completed 119 enrolled Samsung Bioepis Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Bevacizumab

Timeline

Start: 2015-04
Primary completion: 2015-09
Completion: 2015-09

Outcome

Met primary endpoint

paper The 90% CIs for the geometric LSMean ratios of AUCinf, AUClast and Cmax were all within the prespecified bioequivalence margins. PMID 32949267 ↗

Publications

Shin D, Lee YJ, Choi J, Lee D, Park M, Petkova M. A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers. Cancer Chemother Pharmacol. 2020 Oct;86(4):567-575. doi: 10.1007/s00280-020-04144-7. Epub 2020 Sep 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bevacizumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	SB8	Unknown	3 mg/kg	Intravenous

Indications

No indication recorded.