Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

Study Overview
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Brief Summary
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This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed. Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world. All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations. There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.

Official Title
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A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Risankizumab Dose A
* Drug: Risankizumab Dose B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement. Exclusion Criteria: Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment. Intention to perform strenuous exercise to which the participant 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: 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: Risankizumab Dose A<br>Participants will receive subcutaneous dose of risankizumab dose A. | Drug: Risankizumab Dose A<br>* Prefilled Syringe<br>|
| Experimental: Risankizumab Dose B<br>Participants will receive subcutaneous dose of risankizumab dose B. | Drug: Risankizumab Dose B<br>* Prefilled Syringe<br>|

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 (Cmax) | Approximately up to 113 days | 
| Time to Maximum Observed Plasma Concentration (Tmax) | Time to Maximum Observed Plasma Concentration (Tmax) | Approximately up to 113 days | 
| Apparent Terminal Phase Elimination Rate Constant (β) | Apparent Terminal Phase Elimination Rate Constant (β) | Approximately up to 113 days | 
| The Terminal Phase Elimination Half-Life (t1/2) | The Terminal Phase Elimination Half-Life (t1/2) | Approximately up to 113 days | 
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Approximately up to 113 days | 
| The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) | Approximately up to 113 days | 
| Number of Participants with 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. | Approximately up to 140 days | 

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