A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants

Study Identifier
M16-324
CT.gov Identifier
NCT05283694
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • risankizumab
    • Phase
    Phase 1
    Sex
    Male
    Age
    18 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body weight less than 100.00 kg inclusive at Screening and Check-In Day. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
    Exclusion Criteria:
    * Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

    Protocol Summary

    The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.

    Study Locations

    Location
    Status
    Location
    Acpru /Id# 165737
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable