Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers

Summary

This is a randomized, double-blinded, controlled Phase I study of CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB015 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.

Timeline

Start

2023-02-15

Primary completion

2023-07-03

Completion

2023-07-03

Outcome

Met primary endpoint

paper Cmax and AUC0-inf for CMAB015 to secukinumab were all within the bioequivalence limits (80.00-125.00%). PMID 39224901 ↗

Publications

• Yao F, Wang C, Ding J, Zhang Q, Zheng L, Zhang Q, Yang T, Zhang X, Shan Y, Hou S, Wang H, Zhou R, Hu W. A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx(R) in Healthy Chinese Male Subjects. Drug Des Devel Ther. 2024 Aug 29;18:3891-3901. doi: 10.2147/DDDT.S470619. eCollection 2024.

Drugs

Indications