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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Risankizumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Altasciences Clinical Los Angeles, Inc /ID# 164197

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Japanese Participants Receiving Risankizumab; Participants will receive single dose of risankizumab.	Drug: Risankizumab; Intravenous (IV) Infusion; Other Names: ABBV-066; SKYRIZI
EXPERIMENTAL: Japanese Participants Receiving Placebo; Participants will receive single dose of placebo.	Drug: Placebo; Intravenous (IV) Infusion
EXPERIMENTAL: Caucasian Participants Receiving Risankizumab; Participants will receive single dose of risankizumab.	Drug: Risankizumab; Intravenous (IV) Infusion; Other Names: ABBV-066; SKYRIZI
EXPERIMENTAL: Caucasian Participants Receiving Placebo; Participants will receive single dose of placebo.	Drug: Placebo; Intravenous (IV) Infusion

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 23, 2017
• Primary Completion (ACTUAL): June 15, 2018
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (ACTUAL): March 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Risankizumab; Skyrizi
• Other Study ID Numbers: M16-533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No