Clinical Trial

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

Recruiting Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2025-12-15
Trial Details
NCT Number NCT07258745
Lead Sponsor Chong Kun Dang Pharmaceutical
Conditions Psoriasis
Enrollment 213 participants
Start Date 2025-11-26
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-19