A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects

• Main Authors: Hong Zhang (Author), Hong Chen (Author), Xiaojiao Li (Author), Min Wu (Author), Xiaoxue Zhu (Author), Cuiyun Li (Author), Jingrui Liu (Author), Haijing Wei (Author), Yue Hu (Author), Jingjing Wang (Author), Yongmin Yang (Author), Xiangyang Zhu (Author), Yanhua Ding (Author)
• Format: Book
• Published: Frontiers Media S.A., 2021-03-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Objective: This study explored the bioequivalence of a proposed biosimilar HOT-3010 vs. its reference product (adalimumab) among healthy Chinese male subjects. The study also investigated the tolerance, immunogenicity, and pharmacokinetics (PK).Methods: A randomized, double-blind, two-arm, parallel...