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

NCT06951828 | Completed Phase 1 FDA Drug

• 1 other identifier: CT-P43 1.3
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Additional PK evaluation

  Day113

• Safety evaluation by AEs

  Day113

Study Arms (2)

CT-P43 Auto-injector

EXPERIMENTAL

CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)

Biological: CT-P43

CT-P43 Pre-filled syringe

ACTIVE COMPARATOR

CT-P43, 45 mg in 0.5 ml, a single SC injection via pre-filled syringe (PFS)

Biological: CT-P43

Interventions

CT-P43 BIOLOGICAL

CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)

CT-P43 Auto-injector

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

Study Officials

• Hyewon Chung

  Korea University Guro Hospital (Department of Clinical Pharmacology)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: May 30, 2025
• Primary Completion: November 26, 2025
• Study Completion: December 24, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

KR (1)