Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects

NCT01922336 ↗

Phase 1 Completed 159 enrolled Samsung Bioepis Co., Ltd.

RandomizedParallel-groupSingle-blindOther

Summary

The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB2 and Remicade (EU sourced Remicade and US sourced Remicade) in healthy subjects.

Timeline

Start: 2013-07
Primary completion: 2013-10
Completion: 2013-10

Outcome

Met primary endpoint

paper All of the 90 % CIs for the geometric LSMean ratios of primary PK parameters for each comparison were within the pre-defined equivalence margin. PMID 26577771 ↗

Publications

Shin D, Kim Y, Kim YS, Kornicke T, Fuhr R. A Randomized, Phase I Pharmacokinetic Study Comparing SB2 and Infliximab Reference Product (Remicade((R))) in Healthy Subjects. BioDrugs. 2015 Dec;29(6):381-8. doi: 10.1007/s40259-015-0150-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous

Indications

No indication recorded.