Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

Study Overview
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Brief Summary
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The objective of this study is to assess the impact of different warm-up times of risankizumab autoinjector (AI) on the participant injection site pain experience in healthy adult volunteers.

Official Title
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A Randomized, Double-Blind, Three-Period Crossover Study to Evaluate the Effect of Different Warm-Up Times of Risankizumab Autoinjector (AI) on the Injection Pain Experiences in Healthy Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Risankizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Body mass index (BMI) is >= 18.0 to <= 30.0 kg/m2. Exclusion Criteria: Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. Any evidence of a concomitant disease judged as clinically relevant by the investigator. History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any other 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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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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants will receive Regimen A (15-minute autoinjector (AI) warm-up time) in Period 1, Regimen B (30-minute AI warm-up time) in Period 2 followed by Regimen C (45-minute AI warm-up time) in Period 3. | Drug: Risankizumab<br>* Subcutaneous autoinjector<br>* Other names: SKYRIZI;|
| Experimental: Group 2<br>Participants will receive Regimen B in Period 1, Regimen C in Period 2 followed by Regimen A in Period 3. | Drug: Risankizumab<br>* Subcutaneous autoinjector<br>* Other names: SKYRIZI;|
| Experimental: Group 3<br>Participants will receive Regimen C in Period 1, Regimen A in Period 2 followed by Regimen B in Period 3. | Drug: Risankizumab<br>* Subcutaneous autoinjector<br>* Other names: SKYRIZI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Injection Site Pain Assessed Using Visual Analog Scale | Injection site-related pain assessments will be recorded directly by the participant using a VAS after the injection is complete (within approximately 5 minutes and 1 hour post-dose). | Up to approximately 15 days | 
| Percentage of Participants Experiencing Adverse Events | 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 155 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Rated Acceptability Assessed as Change in Self-Injection Assessment Questionnaire (SIAQ) | SIAQ is an electronic patient-reported outcomes (ePRO) device assessing participant acceptability with scores ranging from 0 (worst experience) to 10 (best experience). | Up to approximately 15 days | 

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