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

• Main Authors: Kyung‐Sang Yu (Author), In‐Jin Jang (Author), Hyeong‐Seok Lim (Author), Jang Hee Hong (Author), Min‐Gul Kim (Author), Min Kyu Park (Author), Doo‐Yeoun Cho (Author), Min Soo Park (Author), Jae Yong Chung (Author), Jong‐Lyul Ghim (Author), SeungHwan Lee (Author), Seok Kyu Yoon (Author), In Sun Kwon (Author), Sang Joon Lee (Author), Sung Hyun Kim (Author), Yun Ju Bae (Author), Jung Bin Cha (Author), Daniel E. Furst (Author), Edward Keystone (Author), Jonathan Kay (Author)
• Format: Book
• Published: Wiley, 2021-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract 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 (clini...