Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Bio… (NCT07258745) | Clinical Trial Compass
RecruitingPhase 1
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants
Poland213 participantsStarted 2025-11-26
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Capability of giving signed informed consent and complying with the requirements and restrictions listed in the ICF and Protocol
* Healthy male or female, 18 to 55 years (inclusive) at the time of signing the ICF
* smokes ≤ 10 cigarettes per week within 3 months of screening
* abstain from alcohol from 48 hours prior to study intervention administration and keeping alcohol consumption within WHO limits (more than 14 units per week spread over 3 or more days, equivalent to 6 pints of average strength beer or 6 medium glasses \[175 mL\] of wine)
* have acceptable venous access for blood collection
* Female participants are eligible to participate if they are not pregnant, not breastfeeding
* Male participants must refrain from donating sperm from screening (signing the ICF) until at least 30 days after EOS visit
* All participants must be willing to use effective/highly effective methods of contraception during the study period
* Participants are willing and able to be confined to the clinical unit prior to and during the study intervention administration and required follow-up periods.
Exclusion Criteria:
* History of previous exposure to any anti-IL-12/23 or anti-IL-23 treatment
* History of relevant drug and/or food allergies
* History of hypersensitivity to Skyrizi or their constituents
* Presence of psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
*…