Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects

Phase 1 Completed 190 enrolled Samsung Bioepis Co., Ltd.

RandomizedParallel-groupOpen-labelOther

Summary

The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the pre-filled pen and pre-filled syringe of SB5 in healthy subjects.

Timeline

Start: 2015-06
Primary completion: 2015-09
Completion: 2015-09

Outcome

Met primary endpoint

paper primary endpoints, the 90% CIs for the ratio of geometric least squares means for SB5 AI to SB5 PFS ranged between 0.9503 and 1.2240 PMID 30464411 ↗

paper which were all within the equivalence margin of 0.80-1.25. PMID 30464411 ↗

Publications

Shin D, Lee Y, Jeong D, Ellis-Pegler R. Comparative pharmacokinetics of an adalimumab biosimilar SB5 administered via autoinjector or prefilled syringe in healthy subjects. Drug Des Devel Ther. 2018 Nov 5;12:3799-3805. doi: 10.2147/DDDT.S169082. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous

Indications

No indication recorded.