Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants

Study Identifier
M23-661
CT.gov Identifier
NCT05475821
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • ABBV-990
  • Placebo for ABBV-990
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body Mass Index (BMI) is \>= 18.0 to \<= 32.0 kg/m2. * Laboratory values meet the protocol-specified criteria. * 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). * In the opinion of the investigator, participant is a suitable candidate for enrollment in the study.
    Exclusion Criteria:
    * Have any clinically significant ECG abnormalities. * History of any clinically significant sensitivity or allergy to any medication or food. * Known active SARS-CoV-2 infection at screening and upon initial confinement. * 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. * Currently enrolled in another interventional clinical study.

    Protocol Summary

    This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed.

    ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Each group receives different treatment. There is 1 in 4 chance that participants are assigned to placebo. Approximately 40 adult healthy volunteers will be enrolled in a single site in the United States.

    Participants will receive oral tablet of ABBV-990 or matching placebo on Day 1 and followed for approximately 30 days.

    Participants will be confined for 5 days. Adverse Events and blood tests will be performed.

    Study Locations

    Location
    Status
    Location
    Acpru /Id# 247995
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable