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

Not Applicable

Completed

• Conditions: Healthy Male Subjects
• Interventions: Biological: CT-P55; Biological: EU-approved Cosentyx; Biological: US-licensed Cosentyx

• Registration Number: NCT07054970
• Lead Sponsor: Celltrion

Brief 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.

Study Timeline

• Study Start: 2024-01-12
• Primary Completion: 2024-08-29
• Study Completion: 2024-09-06
• Study First Submitted: 2025-06-22
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 172

Inclusion Criteria

• Healthy male subjects between the ages of 18 and 55 years, both inclusive.
• Body weight between 50.0 kg and 90.0 kg (both inclusive), and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive), when rounded to the nearest tenth.

Exclusion Criteria

• A medical history and/or condition that is considered significant
• Clinically significant allergic reactions, hypersensitivity
• History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis
• Active or latent Tuberculosis
• History of malignancy
• Previous monoclonal antibody or fusion protein treatment, or current use of any biologics
• Planning to be father a child or donate sperm within 22 weeks period following study drug administration.
• Undergone treatment with an investigational drug or participated in another clinical trial within 12weeks or 5 half-lives (whichever is longer)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P55	CT-P55	a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved Cosentyx	EU-approved Cosentyx	a single SC injection via PFS
US-licensed Cosentyx	US-licensed Cosentyx	a single SC injection via PFS

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)	Day 155	Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P55, European Union (EU)-approved Cosentyx and United States (US)-licensed Cosentyx in healthy male subjects. The similarity of PK will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for AUC0-inf.
PK similarity demonstration in terms of maximum serum concentration (Cmax)	Day 155	Demonstrate PK similarity in terms of Cmax of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in healthy male subjects up to Day 155. The similarity of PK will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for Cmax.

Secondary Outcome Measures

Name	Time	Method
Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last)	Day 155
Evaluate additional PK in terms of Time to Cmax (Tmax)	Day155
Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F)	Day 155
Evaluate additional PK in terms of Terminal elimination rate constant (λz)	Day155
Evaluate additional PK in terms of Terminal elimination half-life (t1/2)	Day 155
Evaluate additional PK in terms of Apparent total body clearance (CL/F)	Day155
Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap)	Day 155
Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P55 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	Day 155

Trial Locations

Locations (4)

Yokohama Minoru Clinic; 🇯🇵 Yokohama-shi, Kanagawa, Japan

SOUSEIKAI Nishikumamoto Hospital; 🇯🇵 Kumamoto-shi, Kumamoto, Japan

Medical Corporation Heishinkai OPHAC Hospital; 🇯🇵 Osaka-shi, Osaka, Japan

Kitasato University Kitasato Institute Hospital; 🇯🇵 Minato-ku, Tokyo, Japan