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

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT05305222
Collaborator
(none)
17
Enrollment
1
Location
4
Arms
7.7
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability After a Single Dose of Risankizumab
Actual Study Start Date :
Oct 23, 2017
Actual Primary Completion Date :
Jun 15, 2018
Actual Study Completion Date :
Jun 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Japanese Participants Receiving Risankizumab

Participants will receive single dose of risankizumab.

Drug: Risankizumab
Intravenous (IV) Infusion
Other Names:
  • SKYRIZI
  • ABBV-066

    		•
    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:
  • SKYRIZI
  • ABBV-066

    		•
    Experimental: Caucasian Participants Receiving Placebo

    Participants will receive single dose of placebo.

    Drug: Placebo
    Intravenous (IV) Infusion

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Experiencing Adverse Events [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 [Up to approximately 137 days]

      Maximum observed plasma concentration (Cmax) of Risankizumab.

    3. Time to Cmax (Cmax) of Risankizumab [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 [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 [Up to approximately 137 days]

      AUCinf of Risankizumab.

    6. Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab [Up to approximately 137 days]

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

    7. Terminal Phase Elimination Half-life (t1/2) of Risankizumab [Up to approximately 137 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Altasciences Clinical Los Angeles, Inc /ID# 164197 Cypress California United States 90630

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05305222
    Other Study ID Numbers:
    • M16-533
    First Posted:
    Mar 31, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by AbbVie
    Healthy Volunteers
    Risankizumab
    Skyrizi

    Study Results

    No Results Posted as of Mar 31, 2022