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ACTIVE NOT RECRUITING
NCT07200986
PHASE1

Study to Compare Pharmacokinetics and Safety of CT-P52 and US-licensed Taltz in Healthy Subjects

Sponsor: Celltrion

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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