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

NCT07054970 | Completed Phase 1

• 1 other identifier: CT-P55 1.1
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 4

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)

  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.

  Day 155

• PK similarity demonstration in terms of maximum serum concentration (Cmax)

  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.

  Day 155

Secondary Outcomes (8)

• 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

Study Arms (3)

CT-P55

EXPERIMENTAL

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

Biological: CT-P55

US-licensed Cosentyx

ACTIVE COMPARATOR

a single SC injection via PFS

Biological: US-licensed Cosentyx

EU-approved Cosentyx

ACTIVE COMPARATOR

a single SC injection via PFS

Biological: EU-approved Cosentyx

Interventions

CT-P55 BIOLOGICAL

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

CT-P55

US-licensed Cosentyx BIOLOGICAL

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

US-licensed Cosentyx

EU-approved Cosentyx BIOLOGICAL

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

EU-approved Cosentyx

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Celltrion: lead

Study Sites (4)

Yokohama Minoru Clinic

Yokohama, Kanagawa, 232-0064, Japan

Location

SOUSEIKAI Nishikumamoto Hospital

Kumamoto, Kumamoto, Japan

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

Kitasato University Kitasato Institute Hospital

Minato-ku, Tokyo, 108-8642, Japan

Location

Study Officials

• Tomoko Hasunuma

  Kitasato University Kitasato Institute Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 8, 2025
• Study Start: January 12, 2024
• Primary Completion: August 29, 2024
• Study Completion: September 6, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)