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

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

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...

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Bibliographic Details
Main Authors: Hong Zhang, Hong Chen, Xiaojiao Li, Min Wu, Xiaoxue Zhu, Cuiyun Li, Jingrui Liu, Haijing Wei, Yue Hu, Jingjing Wang, Yongmin Yang, Xiangyang Zhu, Yanhua Ding
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-03-01
Series:Frontiers in Pharmacology
Subjects:
adalimumab
biosimilar
immunogenicity
pharmacokinetics
intersubject variability
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2021.646171/full

Internet

https://www.frontiersin.org/articles/10.3389/fphar.2021.646171/full

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