A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

Study Identifier
M25-681
CT.gov Identifier
NCT06946524
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) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight greater than 40 kg and less than 100 kg at screening and upon initial 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 Criteria:
    * Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening. * Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

    Protocol Summary

    This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

    Study Locations

    Location
    Status
    Location
    Altasciences Clinical Los Angeles /ID# 276446
    Cypress, California, United States, 90630
    Status
    Not applicable
    Location
    Acpru /Id# 275116
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable