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
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.
• 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.