Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 4:53 PM
Study NCT ID:
NCT07367958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P52 in Healthy Male Subjects
Sponsor:
Celltrion
Organization:
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: