Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

Phase 1 Completed 188 enrolled Samsung Bioepis Co., Ltd.

RandomizedParallel-groupSingle-blindOther

Summary

This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

Timeline

Start: 2020-08-13
Primary completion: 2021-05-15
Completion: 2021-05-15

Outcome

Met primary endpoint

paper For the primary endpoints, the geometric LSMean ratios (90% CI) for AUCinf and Cmax were 0.920 (0.8262-1.0239) and 0.984 (0.9126-1.0604), PMID 35776269 ↗

paper placing the corresponding 90% CIs well within the pre-defined bioequivalence margin of 0.80-1.25. PMID 35776269 ↗

Publications

Ahn SS, Lee M, Baek Y, Lee S. A Randomized Pharmacokinetic Study in Healthy Male Subjects Comparing a High-concentration, Citrate-free SB5 Formulation (40 mg/0.4 ml) and Prior SB5 (Adalimumab Biosimilar). Rheumatol Ther. 2022 Aug;9(4):1157-1169. doi: 10.1007/s40744-022-00471-8. Epub 2022 Jul 1.

Drugs

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

Indications

No indication recorded.