To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects

Phase 1 Completed 172 enrolled Celltrion

RandomizedParallel-groupQuadruple-blindOther

Summary

This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects

Timeline

Start: 2024-01-12
Primary completion: 2024-08-29
Completion: 2024-09-06

Publications

Hasunuma T, Yagi M, Nakamichi N, Blauvelt A, Thaci D, Suh J, Cha J, Noh I, Lee E, Papp KA. Pharmacokinetics and safety of candidate biosimilar CT-P55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, Phase I study. Expert Opin Investig Drugs. 2026 Jan-Feb;35(2):179-188. doi: 10.1080/13543784.2026.2628208. Epub 2026 Feb 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CT-P55	Monoclonal antibody	150 mg	Subcutaneous
Comparator	Secukinumab	Monoclonal antibody	150 mg	Subcutaneous

Indications

No indication recorded.