The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
226
Subcutaneous Injection via Prefilled Syringe (PFS)
Subcutaneous Injection via Auto-Injector (AI)
Acpru /Id# 210844
Grayslake, Illinois, United States
PPD Clinical Research Unit - Austin /ID# 211456
Austin, Texas, United States
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Up to 140 Days
Maximum observed serum concentration (Cmax)
Maximum observed serum concentration
Time frame: Up to 113 Days
Time to Cmax (Tmax)
Time to Cmax
Time frame: Up to 113 Days
Terminal phase elimination rate constant (β)
Terminal phase elimination rate constant
Time frame: Up to 113 Days
Terminal phase elimination half-life (t1/2)
Terminal phase elimination half-life
Time frame: Up to 113 Days
Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt)
AUC from 0 to time of last measurable concentration
Time frame: Up to 113 Days
AUC from time 0 to infinity (AUCinf)
AUC from time 0 to infinity
Time frame: Up to 113 Days
Number of Anti-drug antibody (ADA) Titers
Incidence of anti-drug antibodies
Time frame: Up to 113 Days
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