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

NCT ID: NCT05305222

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-06-15

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.

Detailed Description

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Conditions

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Healthy Volunteers

Keywords

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Healthy Volunteers Risankizumab Skyrizi

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Japanese Participants Receiving Risankizumab

Participants will receive single dose of risankizumab.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Intravenous (IV) Infusion

Japanese Participants Receiving Placebo

Participants will receive single dose of placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Intravenous (IV) Infusion

Caucasian Participants Receiving Risankizumab

Participants will receive single dose of risankizumab.

Group Type EXPERIMENTAL

Risankizumab

Intervention Type DRUG

Intravenous (IV) Infusion

Caucasian Participants Receiving Placebo

Participants will receive single dose of placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Intravenous (IV) Infusion

Interventions

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Risankizumab

Intravenous (IV) Infusion

Intervention Type DRUG

Placebo

Intravenous (IV) Infusion

Intervention Type DRUG

Other Intervention Names

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SKYRIZI ABBV-066

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Altasciences Clinical Los Angeles, Inc /ID# 164197

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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M16-533

Identifier Type: -

Identifier Source: org_study_id