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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07367958

Enrollment

218

Registered

2026-01-26

Start date

2026-01-26

Completion date

2026-07-08

Last updated

2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Subjects

Brief summary

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.

Detailed description

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.

Interventions

BIOLOGICALCT-P52

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
PK similarity demonstration by AUC 0-inf	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.
PK similarity demonstration by Cmax	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

Measure	Time frame	Description
Additional PK evaluation by AUC0-last	Day 85	Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last).
Additional PK evaluation by Tmax	Day 85	Evaluate additional PK in terms of time to maximum concentration (Tmax).
Additional PK evaluation by T1/2	Day 85	Evaluate additional PK in terms of terminal half-life (t1/2).
Additional PK evaluation by %AUCext	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).
Safety evaluation by AEs	Day 85	Evaluate safety in terms of adverse events (including treatment-emergent adverse events \[TEAEs\] and serious adverse events\[SAEs\]).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026