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

NCT ID: NCT07054970

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-12
• Study Completion Date: 2024-09-06

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.

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

CT-P55

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Group Type: EXPERIMENTAL

CT-P55

Intervention Type: BIOLOGICAL

150 mg in 1.0 mL, administered as a single SC injection via PFS

US-licensed Cosentyx

a single SC injection via PFS

Group Type: ACTIVE_COMPARATOR

US-licensed Cosentyx

Intervention Type: BIOLOGICAL

150 mg in 1.0 mL, administered as a single SC injection via PFS

EU-approved Cosentyx

a single SC injection via PFS

Group Type: ACTIVE_COMPARATOR

EU-approved Cosentyx

Intervention Type: BIOLOGICAL

150 mg in 1.0 mL, administered as a single SC injection via PFS

Interventions

CT-P55

150 mg in 1.0 mL, administered as a single SC injection via PFS

Intervention Type: BIOLOGICAL

US-licensed Cosentyx

150 mg in 1.0 mL, administered as a single SC injection via PFS

Intervention Type: BIOLOGICAL

EU-approved Cosentyx

150 mg in 1.0 mL, administered as a single SC injection via PFS

Intervention Type: BIOLOGICAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomoko Hasunuma

Role: PRINCIPAL_INVESTIGATOR

Kitasato University Kitasato Institute Hospital

Locations

Yokohama Minoru Clinic

Yokohama, Kanagawa, Japan

SOUSEIKAI Nishikumamoto Hospital

Kumamoto, Kumamoto, Japan

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, Japan

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

CT-P55 1.1

Identifier Type: -

Identifier Source: org_study_id