A phase 1, randomized study to assess the pharmacokinetic comparability of siltuximab derived from two different cell lines in healthy subjects
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 ham...
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Published in | Clinical pharmacology in drug development Vol. 3; no. 4; pp. 328 - 334 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Blackwell Publishing Ltd
01.07.2014
Wiley Subscription Services, Inc |
Subjects | |
Online Access | Get full text |
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Summary: | 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 Cmax and AUC0–84day 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. |
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Bibliography: | ArticleID:CPDD86 Janssen Research & Development, LLC istex:A72C6FFE23F34C1DD779ACFC71070DF6FC66B34A ark:/67375/WNG-MKWXC91V-B |
ISSN: | 2160-763X 2160-7648 |
DOI: | 10.1002/cpdd.86 |