A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab

Study Overview
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Brief Summary
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The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants.

Official Title
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A Study in Healthy Japanese and Caucasian 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: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born to two parents and four grandparents also born in Japan of full Japanese descent. Second generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity. Body Mass Index (BMI) is >= 18.5 and <= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m). Exclusion Criteria: Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Japanese Participants Receiving Risankizumab<br>Participants will receive single dose of risankizumab. | Drug: Risankizumab<br>* Intravenous (IV) Infusion<br>* Other names: ABBV-066;|
| Experimental: Japanese Participants Receiving Placebo<br>Participants will receive single dose of placebo. | Drug: Placebo<br>* Intravenous (IV) Infusion<br>|
| Experimental: Caucasian Participants Receiving Risankizumab<br>Participants will receive single dose of risankizumab. | Drug: Risankizumab<br>* Intravenous (IV) Infusion<br>* Other names: ABBV-066;|
| Experimental: Caucasian Participants Receiving Placebo<br>Participants will receive single dose of placebo. | Drug: Placebo<br>* Intravenous (IV) Infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Adverse Events | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to approximately 137 days | 
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Maximum observed plasma concentration (Cmax) of Risankizumab. | Up to approximately 137 days | 
| Time to Cmax (Cmax) of Risankizumab | Tmax of Risankizumab. | Up to approximately 137 days | 
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab | AUCt of Risankizumab. | Up to approximately 137 days | 
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | AUCinf of Risankizumab. | Up to approximately 137 days | 
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Apparent terminal phase elimination rate constant (β) of Risankizumab. | Up to approximately 137 days | 
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Terminal phase elimination half-life (t1/2) of Risankizumab. | Up to approximately 137 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skyrizi, Healthy Volunteers, Risankizumab