A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study in Healthy Volunteers to Evaluate the Bioavailability of Risankizumab New Formulation in Pre-filled Syringe Relative to 90 mg/mL Formulation in Pre-filled Syringe and Characterization of Risankizumab Pharmacokinetics Using New Formulation in Auto-injector

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Risankizumab
* Drug: Risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female healthy volunteers between 18 and 55 years of age. Body weight less than 110.00 kg inclusive at Screening. Exclusion Criteria: Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Risankizumab Dose A<br>Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days | Drug: Risankizumab<br>* Subcutaneous Injection via Prefilled Syringe (PFS)<br>* Other names: SKYRIZI;|
| Experimental: Risankizumab Dose B<br>Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days | Drug: Risankizumab<br>* Subcutaneous Injection via Prefilled Syringe (PFS)<br>* Other names: SKYRIZI;|
| Experimental: Risankizumab Dose C<br>Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days. | Drug: Risankizumab<br>* Subcutaneous Injection via Auto-Injector (AI)<br>* Other names: SKYRIZI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 140 Days | 
| Maximum observed serum concentration (Cmax) | Maximum observed serum concentration | Up to 113 Days | 
| Time to Cmax (Tmax) | Time to Cmax | Up to 113 Days | 
| Terminal phase elimination rate constant (β) | Terminal phase elimination rate constant | Up to 113 Days | 
| Terminal phase elimination half-life (t1/2) | Terminal phase elimination half-life | 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 | Up to 113 Days | 
| AUC from time 0 to infinity (AUCinf) | AUC from time 0 to infinity | Up to 113 Days | 
| Number of Anti-drug antibody (ADA) Titers | Incidence of anti-drug antibodies | Up to 113 Days |