NCT07367958

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 218 (estimated)
• 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-P52 in Healthy Male Subjects.

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.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
BIOLOGICAL	CT-P52	CT-P52, 80 mg in 1 ml, a single subcutaneous (SC) injection via auto-injector (AI)

Timeline

• Start date: 2026-01-26
• Primary completion: 2026-08-01
• Completion: 2027-01-01
• First posted: 2026-01-26
• Last updated: 2026-04-13

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study