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A phase 1, randomized study to assess the pharmacokinetic comparability of siltuximab derived from two different cell lines in healthy subjects
Author(s) -
Xu Chao,
Han Chao,
Marini Joseph,
Ford Joyce,
Marciniak Stanley,
Lopez Manny,
Frederick Bart,
de Vries Dick,
Bandekar Rajesh,
Davis Hugh M.,
Zhou Honghui,
Puchalski Thomas A.
Publication year - 2013
Publication title -
clinical pharmacology in drug development
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.711
H-Index - 22
eISSN - 2160-7648
pISSN - 2160-763X
DOI - 10.1002/cpdd.86
Subject(s) - medicine , chinese hamster ovary cell , pharmacokinetics , pharmacology , confidence interval , receptor
Siltuximab, a monoclonal antibody (mAb) against interleukin (IL‐6), is under development by Janssen Research & Development, LLC. During early clinical development, siltuximab was produced in a murine Sp2/0 myeloma cell line. The production cell line was switched to stably transfected Chinese hamster ovary (CHO) cell line for subsequent clinical development. A two‐part, parallel‐group, phase 1 study was designed to evaluate the safety and pharmacokinetics (PK) of a single IV administration of Sp2/0‐ and CHO‐derived siltuximab in healthy subjects. The results from this study demonstrated PK comparability of siltuximab produced from Sp2/0 and CHO cell lines. The 90% confidence interval of the ratios of geometric means of C max and AUC 0–84day following 1.4 mg/kg doses was (99.4%, 111.3%) and (98.1%, 109.6%), respectively, both within the pre‐specified comparability range of 80–125%. Siltuximab derived from either the Sp2/0 or CHO cell lines was in general well tolerated and was not found to be immunogenic in this study.