Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Study Identifier
M19-128
CT.gov Identifier
NCT05274100
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 weight less than 100.00 kg at Screening and upon initial confinement.
    Exclusion Criteria:
    \- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

    Protocol Summary

    The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

    Study Locations

    Location
    Status
    Location
    Anaheim Clinical Trials LLC /ID# 222821
    Anaheim, California, United States, 92801-2658
    Status
    Not applicable
    Location
    Altasciences Clinical Los Angeles, Inc /ID# 222238
    Cypress, California, United States, 90630
    Status
    Not applicable
    Location
    Clinical Pharmacology of Miami /ID# 225392
    Miami, Florida, United States, 33014
    Status
    Not applicable
    Location
    PPD Clinical Research Unit /ID# 222362
    Orlando, Florida, United States, 32806-1044
    Status
    Not applicable
    Location
    Acpru /Id# 222349
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable
    Location
    PPD Clinical Research Unit -Las Vegas /ID# 222363
    Las Vegas, Nevada, United States, 89113-2235
    Status
    Not applicable
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