Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Risankizumab
* Drug: Risankizumab
* Drug: Risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Body weight less than 100.00 kg at Screening and upon initial confinement. Exclusion Criteria: - Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Risankizumab Dose A<br>Participants will receive risankizumab dose A. | Drug: Risankizumab<br>* Subcutaneous Injection via prefilled syringe (PFS)<br>* Other names: SKYRIZI;|
| Experimental: Group 2: Risankizumab Dose B<br>Participants will receive risankizumab dose B. | Drug: Risankizumab<br>* Subcutaneous Injection via on-body delivery system (OBDS)<br>* Other names: SKYRIZI;|
| Experimental: Group 3: Risankizumab Dose C<br>Participants will receive risankizumab dose C. | Drug: Risankizumab<br>* Subcutaneous Injection via on-body delivery system (OBDS)<br>* Other names: SKYRIZI;|
| Experimental: Group 4: Risankizumab Dose D<br>Participants will receive risankizumab dose D. | Drug: Risankizumab<br>* Intravenous Infusion<br>* Other names: SKYRIZI;|
| Experimental: Group 5: Risankizumab Dose D<br>Participants will receive risankizumab dose D. | Drug: Risankizumab<br>* Intravenous Infusion<br>* Other names: SKYRIZI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to approximately 140 days | 
| Maximum Observed Serum Concentration (Cmax) | Maximum observed serum concentration (Cmax) of risankizumab. | Up to approximately 113 days | 
| Time to Cmax (Tmax) | Time to Cmax of risankizumab. | Up to approximately 113 days | 
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent terminal phase elimination rate constant (β) of risankizumab. | Up to approximately 113 days | 
| Terminal Phase Elimination Hhalf-life (t1/2) | Terminal phase elimination half-life (t1/2) of risankizumab. | 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. | Up to approximately 113 days | 
| AUC From Time 0 to Infinity (AUCinf) | AUCinf of risankizumab. | Up to approximately 113 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risankizumab, SKYRIZI