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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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Detalles Bibliográficos
Autores principales: Zhang, Hong, Chen, Hong, Li, Xiaojiao, Wu, Min, Zhu, Xiaoxue, Li, Cuiyun, Liu, Jingrui, Wei, Haijing, Hu, Yue, Wang, Jingjing, Yang, Yongmin, Zhu, Xiangyang, Ding, Yanhua
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8190825/
https://www.ncbi.nlm.nih.gov/pubmed/34122068
http://dx.doi.org/10.3389/fphar.2021.646171