RecruitingPhase 1NCT07258745

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

Sponsor

Chong Kun Dang Pharmaceutical

Enrollment

213 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

Psoriasis

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CKD-704, a biological treatment called SKYRIZI, and others for people with psoriasis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSKYRIZI

EU-sourced

BIOLOGICALSKYRIZI

US-licensed

BIOLOGICALCKD-704

Risankizumab biosimilar

Locations(1)

MTZ powered by Pratia

Warsaw, Warszawa, Poland

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NCT07258745

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