A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Study Identifier
M24-460
CT.gov Identifier
NCT06487572
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 - 65 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 particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

    Protocol Summary

    The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.

    Study Locations

    Location
    Status
    Location
    Clinical Pharmacology Of Miami /ID# 268219
    Miami, Florida, United States, 33014
    Status
    Not applicable
    Location
    Acpru /Id# 267057
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable