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Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects

 Kyung-Sang Yu  ;  In-Jin Jang  ;  Hyeong-Seok Lim  ;  Jang Hee Hong  ;  Min-Gul Kim  ;  Min Kyu Park  ;  Doo-Yeoun Cho  ;  Min Soo Park  ;  Jae Yong Chung  ;  Jong-Lyul Ghim  ;  SeungHwan Lee  ;  Seok Kyu Yoon  ;  In Sun Kwon  ;  Sang Joon Lee  ;  Sung Hyun Kim  ;  Yun Ju Bae  ;  Jung Bin Cha  ;  Daniel E Furst  ;  Edward Keystone  ;  Jonathan Kay 
 Clinical and Translational Science, Vol.14(4) : 1280-1291, 2021-07 
Journal Title
Clinical and Translational Science
Issue Date
Adalimumab / administration & dosage ; Adalimumab / adverse effects ; Adalimumab / pharmacokinetics* ; Adult ; Area Under Curve ; Biosimilar Pharmaceuticals / administration & dosage ; Biosimilar Pharmaceuticals / adverse effects ; Biosimilar Pharmaceuticals / pharmacokinetics* ; Double-Blind Method ; Female ; Healthy Volunteers ; Humans ; Injections, Subcutaneous ; Male ; Middle Aged ; Republic of Korea ; Therapeutic Equivalency ; Tumor Necrosis Factor Inhibitors / administration & dosage ; Tumor Necrosis Factor Inhibitors / adverse effects ; Tumor Necrosis Factor Inhibitors / pharmacokinetics* ; Young Adult
This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC0-inf ); AUC from time zero to the last quantifiable concentration (AUC0-last ); and maximum serum concentration (Cmax ). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT-P17; 103 US-adalimumab; 106 EU-adalimumab), 308 subjects received study drug. AUC0-inf , AUC0-last , and Cmax were equivalent among CT-P17, US-adalimumab, and EU-adalimumab, because 90% CIs for the ratios of GLSMs were within the 80-125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single-dose administration of CT-P17, EU-adalimumab, and US-adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars.
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