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Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
Sponsor: Celltrion
Summary
This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
Official title: A Phase 1, Randomized, Double-blind, Two-arm, Parallel-Group, Single-dose Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects
Key Details
Gender
All
Age Range
19 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
218
Start Date
2025-09-17
Completion Date
2026-03-31
Last Updated
2025-12-31
Healthy Volunteers
Yes
Conditions
Interventions
Ixekizumab
80 mg (single dose), SC injection via PFS
Locations (5)
Inje University Busan Paik Hospital
Busan, Busanjin-gu, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital
Seoul, South Korea