A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

Last updated: May 14, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Risankizumab

Clinical Study ID

NCT06571266
M24-342
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement

  • Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenthsdecimal, at Screening and upon confinement.

  • A condition of general good health, based upon the results of a medical history,physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion

Exclusion Criteria:

  • Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23treatment for at least one year prior to Screening.

  • Participant with intention to perform strenuous exercise within at least one weekprior to administration of study drug or during the study.

  • History of epilepsy, any clinically significant cardiac, respiratory (except mildasthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatricdisease or disorder, or any uncontrolled medical illness.

Study Design

Total Participants: 231
Treatment Group(s): 1
Primary Treatment: Risankizumab
Phase: 1
Study Start date:
September 11, 2024
Estimated Completion Date:
April 16, 2025

Connect with a study center

  • Cenexel Act /ID# 270310

    Anaheim, California 92801
    United States

    Site Not Available

  • Collaborative Neuroscience Research CNS /ID# 270286

    Los Alamitos, California 90720
    United States

    Site Not Available

  • Acpru /Id# 270152

    Grayslake, Illinois 60030
    United States

    Site Not Available

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