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)
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
Parallel
SKYRIZI
Biological/VaccineEU-sourced
SKYRIZI
Biological/VaccineUS-licensed
CKD-704
Biological/VaccineRisankizumab biosimilar
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of risankizumab.
AUC From Time 0 to Infinity (AUCinf)
AUCinf of risankizumab
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
AUCt of risankizumab
Terminal Phase Elimination Hhalf-life (t1/2)
Terminal phase elimination half-life (t1/2) of risankizumab.
Time to Cmax (Tmax)
Time to Cmax of risankizumab
Safety and tolerability
Incidence and characteristics (severity, etc) of AEs
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