A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

Study Identifier
M15-990
CT.gov Identifier
NCT05283681
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 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male and female healthy volunteers between 18 and 55 years of age. * Body weight less than 110.00 kg inclusive at Screening.
    Exclusion Criteria:
    * Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. * Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.

    Protocol Summary

    The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

    Study Locations

    Location
    Status
    Location
    Acpru /Id# 210844
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable
    Location
    PPD Clinical Research Unit - Austin /ID# 211456
    Austin, Texas, United States, 78744
    Status
    Not applicable