A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

Study Identifier
M24-696
CT.gov Identifier
NCT06054425
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/m2 after rounding to the tenths decimal at the time of 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 electrocardiogram (ECG). * Body weight less than 100.00 kg at Screening and upon initial confinement.
    Exclusion Criteria:
    * History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. * Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.

    Protocol Summary

    The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).

    Study Locations

    Location
    Status
    Location
    Anaheim Clinical Trials LLC /ID# 260740
    Anaheim, California, United States, 92801-2658
    Status
    Not applicable
    Location
    Clinical Pharmacology of Miami /ID# 260800
    Miami, Florida, United States, 33014
    Status
    Not applicable
    Location
    Acpru /Id# 260864
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable