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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
213
MTZ powered by Pratia
Warsaw, Warszawa, Poland
RECRUITINGMaximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of risankizumab.
Time frame: up to approximately 146 days
AUC From Time 0 to Infinity (AUCinf)
AUCinf of risankizumab
Time frame: Up to approximately 146 days
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
AUCt of risankizumab
Time frame: Up to approximately 146 days
Terminal Phase Elimination Hhalf-life (t1/2)
Terminal phase elimination half-life (t1/2) of risankizumab.
Time frame: Up to approximately 146 days
Time to Cmax (Tmax)
Time to Cmax of risankizumab
Time frame: Up to approximately 146 days
Safety and tolerability
Incidence and characteristics (severity, etc) of AEs
Time frame: Up to approximately 146 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.