Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants

Study Identifier
M23-506
CT.gov Identifier
NCT05556226
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
  • ABBV-154 Dose Formulation A
  • ABBV-154 Dose Formulation B
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 60 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.
    Exclusion Criteria:
    * Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration. * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness. * Prior exposure to similar biologic therapies.

    Protocol Summary

    This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.

    ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.

    All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.

    There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.

    Study Locations

    Location
    Status
    Location
    Acpru /Id# 250429
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable
    Location
    PPD Clinical Research Unit -Las Vegas /ID# 250650
    Las Vegas, Nevada, United States, 89113-2235
    Status
    Not applicable