Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

NCT05576454 ↗

Phase 1 Completed 207 enrolled Bio-Thera Solutions

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.

Timeline

Start: 2022-09-20
Primary completion: 2023-05-26
Completion: 2023-06-19

Outcome

Met primary endpoint

paper The 90% confidence intervals of the geometric mean ratios of maximum concentration and area under the curve from time 0 to infinity were within 80.00%-125.00%. PMID 40786037 ↗

paper BAT2606 injection was pharmacokinetically bioequivalent to Nucala-US and Nucala-EU in healthy Chinese men. PMID 40786037 ↗

Publications

Li C, Sun J, Xu J, Wu M, Li X, Liu Z, Dong Q, Sun Y, Ding Y. 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. Front Pharmacol. 2025 Jul 25;16:1580883. doi: 10.3389/fphar.2025.1580883. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAT2606	Unknown	100 mg	Subcutaneous
Comparator	Mepolizumab	Monoclonal antibody	100 mg	Subcutaneous