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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Biological: CT-P52

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.

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul (Seoul Special City)
    • Seoul, Seoul (Seoul Special City), South Korea, 08308
      • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-P52 Auto-injector; CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)	Biological: CT-P52; CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)
Active Comparator: CT-P52 Pre-filled syringe; CT-P52, 80 mg in 1 ml, a single SC injection via pre-filled syringe (PFS)	Biological: CT-P52; CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK similarity demonstration by AUC 0-inf	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.	Day 85
PK similarity demonstration by Cmax	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.	Day 85

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CT-P52 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No