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Completed

NCT Number: NCT05305222

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles, Inc /ID# 164197

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risankizumab

Drug

Intravenous (IV) Infusion

Other names: SKYRIZI, ABBV-066

Placebo

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 137 days

    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.

  2. Maximum Observed Plasma Concentration (Cmax) of Risankizumab

    Time frame: Up to approximately 137 days

    Maximum observed plasma concentration (Cmax) of Risankizumab.

  3. Time to Cmax (Cmax) of Risankizumab

    Time frame: Up to approximately 137 days

    Tmax of Risankizumab.

  4. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab

    Time frame: Up to approximately 137 days

    AUCt of Risankizumab.

  5. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab

    Time frame: Up to approximately 137 days

    AUCinf of Risankizumab.

  6. Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab

    Time frame: Up to approximately 137 days

    Apparent terminal phase elimination rate constant (β) of Risankizumab.

  7. Terminal Phase Elimination Half-life (t1/2) of Risankizumab

    Time frame: Up to approximately 137 days

    Terminal phase elimination half-life (t1/2) of Risankizumab.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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