Comparative Study of Pharmacokinetics, Safety, Tolerability, and Immunogenicity of CKD-704 and Risankizumab in Moderate-to-Severe Inflammatory Conditions

The primary objective of this study is to compare the pharmacokinetics, safety, tolerability, and immunogenicity of CKD-704, a risankizumab biosimilar, against both the European Union-approved and United States-licensed versions of Skyrizi in healthy adult participants. This comparison is essential to establish the biological similarity and clinical equivalence of the biosimilar candidate to its reference products. The scope of this study includes 6: pharmacokinetic, 4: safety, and immunogenicity assessments.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers across both male and female genders. The participants fall within the age range corresponding to code 3. The study population may include vulnerable groups.

This Phase 1 clinical trial is designed as a comparative study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of CKD-704, a risankizumab biosimilar, in relation to the EU-approved and US-licensed versions of Skyrizi. The study will be conducted in healthy adult participants. The research methodology includes a screening visit for eligibility assessment, followed by scheduled study visits to monitor physiological responses and biological markers. The clinical investigation concludes with an end-of-study visit. The overall duration of the trial, from estimated recruitment to completion, is projected to occur between October 2025 and August 2026. Conditions necessitating early termination from the study may be implemented based on protocol-defined safety criteria or clinical requirements.

The assessment of efficacy in this clinical trial is focused on evaluating the impact on psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.