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

NCT05305222 | Completed Phase 1 FDA Drug

• 1 other identifier: M16-533
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Risankizumab; Skyrizi

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (4)

Japanese Participants Receiving Risankizumab

EXPERIMENTAL

Participants will receive single dose of risankizumab.

Drug: Risankizumab

Japanese Participants Receiving Placebo

EXPERIMENTAL

Participants will receive single dose of placebo.

Drug: Placebo

Caucasian Participants Receiving Risankizumab

EXPERIMENTAL

Participants will receive single dose of risankizumab.

Drug: Risankizumab

Caucasian Participants Receiving Placebo

EXPERIMENTAL

Participants will receive single dose of placebo.

Drug: Placebo

Interventions

Risankizumab DRUG

Intravenous (IV) Infusion

Also known as: SKYRIZI, ABBV-066

Caucasian Participants Receiving Risankizumab; Japanese Participants Receiving Risankizumab

Placebo DRUG

Intravenous (IV) Infusion

Caucasian Participants Receiving Placebo; Japanese Participants Receiving Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Altasciences Clinical Los Angeles, Inc /ID# 164197

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

risankizumab

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: March 31, 2022
• Study Start: October 23, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)