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Completed

NCT Number: NCT07054970

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

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

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Key information

Conditions

Healthy Male Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yokohama Minoru Clinic, Yokohama, Kanagawa, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CT-P55

Biological

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

US-licensed Cosentyx

Biological

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

EU-approved Cosentyx

Biological

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last)

    Time frame: Day 155

  2. Evaluate additional PK in terms of Time to Cmax (Tmax)

    Time frame: Day155

  3. Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F)

    Time frame: Day 155

  4. Evaluate additional PK in terms of Terminal elimination rate constant (λz)

    Time frame: Day155

  5. Evaluate additional PK in terms of Terminal elimination half-life (t1/2)

    Time frame: Day 155

  6. Evaluate additional PK in terms of Apparent total body clearance (CL/F)

    Time frame: Day155

  7. Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap)

    Time frame: Day 155

  8. 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.

    Time frame: Day 155

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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