Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial

Comparison of pharmacokinetic similarity, immunogenicity, and safety of mepolizumab and BAT2606 in healthy Chinese men in a double-blinded, randomized, single-dose, three-arm parallel-group phase I trial

ObjectiveTo evaluate the similarity of BAT2606 and mepolizumab, including pharmacokinetic profiles, immunogenicity, and safety, in healthy Chinese men.MethodsThis randomized, double-blind, parallel three-arm, single-dose Phase I clinical study enrolled 207 subjects. All subjects enrolled in this stu...

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Bibliographic Details
Main Authors: Cuiyun Li, Jixuan Sun, Jia Xu, Min Wu, Xiaojiao Li, Zhijie Liu, Qingfeng Dong, Yu Sun, Yanhua Ding
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Pharmacology
Subjects:
BAT2606 injection
biosimilar
mepolizumab
pharmacokinetics
safety
immunogenicity
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1580883/full
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