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Completed

NCT Number: NCT07367958

A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects

This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 in Healthy Male Subjects.

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Key information

Conditions

Healthy Male Subjects

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Guro Hospital

Seoul, Seoul (Seoul Special City), 08308, South Korea

About this study

CT-P52, containing the active ingredient ixekizumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Taltz. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P52 will be 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 19 and 55 years, both inclusive.
  • Subject has a body weight between 60 to 90 kg, both inclusive, and a BMI between 18.0 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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
  • Active or latent Tuberculosis
  • History of malignancy
  • Previous exposure to ixekizumab or a biosimilar of ixekizumab or any drug that directly targets Interleukin (IL)-17 or the IL-17 receptor

Treatment and study plan

CT-P52

Biological

CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)

Primary outcomes

  1. PK similarity demonstration by AUC 0-inf

    Time frame: Day 85

    Demonstrate the PK similarity in terms of area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P52 SC administration via AI versus PFS in healthy male subjects up to Day 85.

  2. PK similarity demonstration by Cmax

    Time frame: Day 85

    Demonstrate the PK similarity in terms of maximum serum concentration (Cmax) of CT-P52 SC administration via AI versus PFS in healthy male subjects up to Day 85.

Secondary outcomes

  1. Additional PK evaluation by AUC0-last

    Time frame: Day 85

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

  2. Additional PK evaluation by Tmax

    Time frame: Day 85

    Evaluate additional PK in terms of time to maximum concentration (Tmax).

  3. Additional PK evaluation by T1/2

    Time frame: Day 85

    Evaluate additional PK in terms of terminal half-life (t1/2).

  4. Additional PK evaluation by %AUCext

    Time frame: Day 85

    Evaluate additional PK in terms of percentage of area under the concentration-time curve from time zero to infinity (AUC0-inf) obtained by extrapolation (%AUCext).

  5. Safety evaluation by AEs

    Time frame: Day 85

    Evaluate safety in terms of adverse events (including treatment-emergent adverse events [TEAEs] and serious adverse events[SAEs]).

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label, Two-arm, Parallel-Group, Single-dose Study to Compare Pharmacokinetics and Safety of CT-P52 AI and CT-P52 PFS in Healthy Male Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jul 17, 2026

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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