This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
263
Subcutaneous Injection
CenExel ACT- Anaheim Clinical Trials /ID# 274805
Anaheim, California, United States
Collaborative Neuroscience Research CNS /ID# 275212
Los Alamitos, California, United States
Cpmi /Id# 274464
Miami, Florida, United States
Acpru /Id# 271954
Grayslake, Illinois, United States
Maximum Observed Plasma Concentration (Cmax) of Risankizumab
Maximum observed plasma concentration (Cmax) of Risankizumab
Time frame: Up to approximately 140 days
Time to Cmax (Tmax) of Risankizumab
Tmax of Risankizumab
Time frame: Up to approximately 140 days
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
Apparent terminal phase elimination rate constant (β) of Risankizumab
Time frame: Up to approximately 140 days
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
Terminal phase elimination half-life (t1/2) of Risankizumab
Time frame: Up to approximately 140 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab
AUCt of Risankizumab
Time frame: Up to approximately 140 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
AUCinf of Risankizumab
Time frame: Up to approximately 140 days
Number of Anti-drug antibody (ADA) Titers
Incidence and concentration of anti-drug antibodies
Time frame: Up to approximately 140 days
Number of Participants Experiencing Adverse Events
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
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Time frame: Up to approximately 140 days