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RECRUITING
NCT07258745
PHASE1

Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants

Sponsor: Chong Kun Dang Pharmaceutical

View on ClinicalTrials.gov

Summary

This is a Phase 1, first-in-human (FIH), randomized, double-blind, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.

Official title: A Randomized, Double-Blind, Single-Dose, Parallel-Group, Three-Arm Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Profiles of CKD-704 (Risankizumab Biosimilar), EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

213

Start Date

2025-11-26

Completion Date

2026-09-30

Last Updated

2025-12-19

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

SKYRIZI

EU-sourced

BIOLOGICAL

SKYRIZI

US-licensed

BIOLOGICAL

CKD-704

Risankizumab biosimilar

Locations (1)

MTZ powered by Pratia

Warsaw, Warszawa, Poland