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

Phase 1

Not yet recruiting

• Conditions: Healthy Male Subjects
• Interventions: Biological: CT-P43

• Registration Number: NCT06951828
• Lead Sponsor: Celltrion

Brief Summary

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.

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-23
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P43 Auto-injector	CT-P43	CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)
CT-P43 Pre-filled syringe	CT-P43	CT-P43, 45 mg in 0.5 ml, a single SC injection via pre-filled syringe (PFS)

Primary Outcome Measures

Name	Time	Method
PK similarity demonstration by AUC 0-inf	Day113	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).
PK similarity demonstration by Cmax	Day113	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).

Secondary Outcome Measures

Name	Time	Method
Additional PK evaluation	Day113	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).
Safety evaluation by AEs	Day113	Evaluate safety in terms of adverse events (including treatment-emergent adverse events \[TEAEs\] and serious adverse events\[SAEs\]).

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Guro-gu, Korea, Republic of