AB0402 PHARMACOKINETICS AND SAFETY OF CT-P47, A PROPOSED TOCILIZUMAB BIOSIMILAR, IN COMPARISON WITH EU-APPROVED TOCILIZUMAB; A PHASE 1, RANDOMIZED, DOUBLE-BLIND, TWO-ARM, SINGLE-DOSE STUDY IN HEALTHY SUBJECTS

K S Yu,B Kim,D Shin,M K Park,J G Hwang,M Kim,H Chung,J Ghim,J Y Chung,J S Smolen,G R Burmester,S H Kim,Y Bae,D Jeon,G Yang,J Yoo,J Bae,E Keystone

doi:10.1136/annrheumdis-2023-eular.268

AB0402 PHARMACOKINETICS AND SAFETY OF CT-P47, A PROPOSED TOCILIZUMAB BIOSIMILAR, IN COMPARISON WITH EU-APPROVED TOCILIZUMAB; A PHASE 1, RANDOMIZED, DOUBLE-BLIND, TWO-ARM, SINGLE-DOSE STUDY IN HEALTHY SUBJECTS

K S Yu, B Kim + Show 16 more

Open Access

https://doi.org/10.1136/annrheumdis-2023-eular.268

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Journal: Annals of the Rheumatic Diseases

Publication Date: May 30, 2023

Affiliation: Seoul National University, Gachon University Gil Medical Center, Chungbuk National University Hospital, Jeonbuk National University, Korea University Medical Center, Inje University Busan Paik Hospital, Seoul National University Bundang Hospital, Medical University of Vienna, Charité - Universitätsmedizin Berlin, Celltrion (South Korea), University of Toronto

#Treatment-emergent Adverse Event #Primary Pharmacokinetics + Show 8 more

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Abstract

BackgroundCT-P47 is a recombinant humanized monoclonal antibody that was developed as a proposed biosimilar of tocilizumab.ObjectivesThe purpose of this study was to compare the pharmacokinetics (PK), safety, and immunogenicity of...

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