A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

Phase 1 Completed 300 enrolled Bio-Thera Solutions

RandomizedParallel-groupDouble-blindBasic science

Summary

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

Timeline

Start: 2023-08-29
Primary completion: 2024-10-08
Completion: 2024-10-08

Publications

Yang Q, Jiang Y, Liu Z, Wu J, Dong Q, Liu Y, Qin H, Zhang Q, Zhang Q, Hu W. A randomized, double-blind, single-dose, parallel two-group study comparing the pharmacokinetics, safety, and immunogenicity of BAT1806 SC with tocilizumab in healthy Chinese male subjects. Expert Opin Biol Ther. 2025 Oct;25(10):1101-1111. doi: 10.1080/14712598.2025.2574006. Epub 2025 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BAT1806	Unknown	162 mg	Subcutaneous
Subject	Tocilizumab	Monoclonal antibody	162 mg	Subcutaneous

Indications

No indication recorded.