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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
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
SKYRIZI
EU-sourced
SKYRIZI
US-licensed
CKD-704
Risankizumab biosimilar
Locations (1)
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Warsaw, Warszawa, Poland