NCT07054970

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Celltrion · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

CT-P55, containing the active ingredient secukinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Cosentyx. In this study, Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx were evaluated in Healthy Male Subjects.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
BIOLOGICAL	CT-P55	150 mg in 1.0 mL, administered as a single SC injection via PFS
BIOLOGICAL	US-licensed Cosentyx	150 mg in 1.0 mL, administered as a single SC injection via PFS
BIOLOGICAL	EU-approved Cosentyx	150 mg in 1.0 mL, administered as a single SC injection via PFS

Timeline

• Start date: 2024-01-12
• Primary completion: 2024-08-29
• Completion: 2024-09-06
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

4 sites across 1 country: Japan