NCT07258745

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
BIOLOGICAL	SKYRIZI	EU-sourced
BIOLOGICAL	SKYRIZI	US-licensed
BIOLOGICAL	CKD-704	Risankizumab biosimilar

Timeline

• Start date: 2025-11-26
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-12-02
• Last updated: 2025-12-19

Locations

1 site across 1 country: Poland