A Phase 1 interventional study of Risankizumab and Risankizumab in Healthy Volunteers, sponsored by AbbVie. Completed at 8 sites in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-10.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive risankizumab dose A.
Drug: Risankizumab
Participants will receive risankizumab dose B.
Drug: Risankizumab
Participants will receive risankizumab dose C.
Drug: Risankizumab
Participants will receive risankizumab dose D.
Drug: Risankizumab
Participants will receive risankizumab dose D.
Drug: Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Also known as: SKYRIZI
Intravenous Infusion
Also known as: SKYRIZI
Subcutaneous Injection via on-body delivery system (OBDS)
Also known as: SKYRIZI
Percentage of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time frame: Up to approximately 140 days
Maximum Observed Serum Concentration (Cmax)
Maximum observed serum concentration (Cmax) of risankizumab.
Time frame: Up to approximately 113 days
Time to Cmax (Tmax)
Time to Cmax of risankizumab.
Time frame: Up to approximately 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent terminal phase elimination rate constant (β) of risankizumab.
Time frame: Up to approximately 113 days
Terminal Phase Elimination Hhalf-life (t1/2)
Terminal phase elimination half-life (t1/2) of risankizumab.
Time frame: Up to approximately 113 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 113 days
AUC From Time 0 to Infinity (AUCinf)
AUCinf of risankizumab.
Time frame: Up to approximately 113 days
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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