A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

Study Identifier
M25-814
CT.gov Identifier
NCT07007091
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
    Female & Male
    Age
    18 - 60 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight between 40 kg and 100 kg, inclusive, at the time of screening. * 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 Criteria:
    * Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening. * Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

    Protocol Summary

    This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

    Study Locations

    Location
    Status
    Location
    Cpmi /Id# 276490
    Miami, Florida, United States, 33172
    Status
    Not applicable
    Location
    Acpru /Id# 276043
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable
    Location
    Ppd - Las Vegas Research Unit /ID# 276565
    Las Vegas, Nevada, United States, 89113
    Status
    Not applicable
    Location
    PPD Phase I Clinic /ID# 276525
    Austin, Texas, United States, 78744
    Status
    Not applicable