NCT06951828

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Celltrion · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-05-30
• Primary completion: 2025-11-26
• Completion: 2025-12-24
• First posted: 2025-04-30
• Last updated: 2026-02-24

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study