A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects

A Phase I, Randomized, Open-label, Two-Arm, Parallel Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled Syringe of CT-P43 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-P43 in Healthy Male Subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Biological: CT-P43; Biological: CT-P43

Detailed Description

CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 will be evaluated in Healthy Male Subjects.

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Guro-gu
    • Seoul, Guro-gu, 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 18.5 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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
• Active or latent Tuberculosis
• History of malignancy
• Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23

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-P43 Auto-injector; CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)	Biological: CT-P43; CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI); Biological: CT-P43; CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Active Comparator: CT-P43 Pre-filled syringe; CT-P43, 45 mg in 0.5 ml, a single SC injection via pre-filled syringe (PFS)	Biological: CT-P43; CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI); Biological: CT-P43; CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

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-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16).	Day113
PK similarity demonstration by Cmax	Demonstrate the PK similarity in terms of maximum serum concentration (Cmax) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16).	Day113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional PK evaluation	Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last). Time to maximum concentration (Tmax), Terminal half-life (t1/2), Percentage of AUC0-inf obtained by extrapolation (%AUCextrap).	Day113
Safety evaluation by AEs	Evaluate safety in terms of adverse events (including treatment-emergent adverse events [TEAEs] and serious adverse events[SAEs]).	Day113

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Principal Investigator: Hyewon Chung, Korea University Guro Hospital (Department of Clinical Pharmacology)

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2025
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): December 24, 2025

Study Registration Dates

• First Submitted: April 23, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CT-P43 1.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No