A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

Study Overview
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Brief Summary
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The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

Official Title
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A Randomized Open-Label Single Dose Study to Evaluate the Effect of Rate and Volume of Administration on the Bioavailability of Risankizumab Following Subcutaneous (SC) Dosing in Healthy Volunteers

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: Body weight less than 100.00 kg inclusive at Screening and Check-In Day. Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement. Exclusion Criteria: Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

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 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days. | Drug: risankizumab<br>* Subcutaneous Injection via prepared syringe<br>* Other names: SKYRIZI;|
| Experimental: Risankizumab Dose B<br>Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days. | Drug: risankizumab<br>* Subcutaneous Injection via syringe pump<br>* Other names: SKYRIZI;|
| Experimental: Risankizumab Dose C<br>Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days. | Drug: risankizumab<br>* Subcutaneous Injection via syringe pump<br>* Other names: SKYRIZI;|
| Experimental: Risankizumab Dose D<br>Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days. | Drug: risankizumab<br>* Subcutaneous Injection via prepared syringe<br>* Other names: SKYRIZI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration | Up to 140 Days | 
| Time to maximum observed plasma concentration (Tmax) | Time to maximum observed plasma concentration | Up to 140 Days | 
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) | AUC from time 0 to the time of last measurable concentration | Up to 140 Days | 
| AUC from time 0 to infinity (AUCinf) | AUC from time 0 to infinity | Up to 140 Days | 
| Terminal phase elimination rate constant (β) | Terminal phase elimination rate constant | Up to 140 Days | 
| Terminal phase elimination half-life (t1/2). | Terminal phase elimination half-life | Up to 140 Days | 
| Number of Anti-drug antibody (ADA) Titers | Incidence of anti-drug antibodies | Up to 140 Days | 
| 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 |