A Study of Intravenously (IV) Infused or Subcutaneously (SC) Injected Risankizumab in Healthy Adult Participants in China

Study Overview
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Brief Summary
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The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.

Official Title
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A Phase 1 Study in Healthy Chinese Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab

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 Mass Index (BMI) is >= 19.0 to <= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters. 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: 45 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: Dose A of Risankizumab for Subcutaneous (SC) Injection<br>Participants will receive SC injections of risankizumab at dose A and then followed for 140 days. | Drug: Risankizumab<br>* Subcutaneous (SC) Injection<br>* Other names: SKYRIZI;|
| Experimental: Dose B of Risankizumab for Subcutaneous (SC) Injection<br>Participants will receive SC injections of risankizumab at dose B and then followed for 140 days. | Drug: Risankizumab<br>* Subcutaneous (SC) Injection<br>* Other names: SKYRIZI;|
| Experimental: Dose C of Risankizumab for Intravenous (IV) Infusion<br>Participants will receive IV infusion of risankizumab at dose C and then followed for 140 days. | Drug: Risankizumab<br>* Intravenous (IV) Infusion<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 (AE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to Approximately 140 Days | 
| Maximum Observed Concentration (Cmax) | Maximum observed concentration. | Up to Approximately 140 Days | 
| Time to Cmax (Tmax) | Time to Cmax. | Up to Approximately 140 Days | 
| Terminal Phase Elimination Rate Constant (β) | Terminal phase elimination rate constant. | Up to Approximately 140 Days | 
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life. | Up to Approximately 140 Days | 
| Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | AUC from time 0 to time of the last measurable concentration (AUCt). | Up to Approximately 140 Days | 
| AUC from Time 0 to Infinity (AUCinf) | AUC from time 0 to infinity (AUCinf). | Up to Approximately 140 Days | 
| Apparent Clearance (CL/F) for Subcutaneous (SC) dosing | CL/F for SC dosing. | Up to Approximately 140 Days | 
| Clearance (CL) for Intravenous (IV) Dosing | CL for IV dosing. | Up to Approximately 140 Days | 
| Number of Anti-drug antibody (ADA) Titers | ADA titers will be tabulated for each participant at the respective study visits. | Up to Approximately 140 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers, Risankizumab, ABBV-066, SKYRIZI