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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05305222

M16-533

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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17 participants in 4 patient groups

Japanese Participants Receiving Risankizumab

Experimental group

Description:

Participants will receive single dose of risankizumab.

Treatment:

Drug: Risankizumab

Japanese Participants Receiving Placebo

Experimental group

Description:

Participants will receive single dose of placebo.

Treatment:

Drug: Placebo

Caucasian Participants Receiving Risankizumab

Experimental group

Description:

Participants will receive single dose of risankizumab.

Treatment:

Drug: Risankizumab

Caucasian Participants Receiving Placebo

Experimental group

Description:

Participants will receive single dose of placebo.

Treatment:

Drug: Placebo