A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections

Study Identifier
M26-058
CT.gov Identifier
NCT07232004
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • ABBV-547
  • ABBV-547 Placebo
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion 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). * Part 1: BMI is \>= 18.0 to \<= 29.9 kg/m\^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Part 2: must have discontinued use of phototherapy (e.g., UVA or UVB) at least 2 weeks prior to the baseline visit (Day 1) and PUVA phototherapy at least 4 weeks prior to the baseline visit (Day 1).
    Exclusion Criteria:
    * History of any clinically significant sensitivity or allergy to any medication or food. * Part 2: uses any herbal supplements within the 2-week period prior to study treatment administration. * Part 2: received any biologics including investigational agents within 2.5 half-lives prior to Baseline.

    Protocol Summary

    The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan.

    There will be 2 parts to this study. In Part 1, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Approximately 87 adult participants will be enrolled at approximately 21 sites in the United States and Japan.

    Participants will be administered one dose of ABBV-547 or placebo.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    CenExel ACT- Anaheim Clinical Trials /ID# 279612
    Anaheim, California, United States, 92801
    Status
    Recruiting
    Location
    Acpru /Id# 278638
    Grayslake, Illinois, United States, 60030
    Status
    Recruiting