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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
AbbVie
Study ID
NCT07232004
Phase
PHASE1
Status
Recruiting

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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 7 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 121 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.

Key Dates

First listed
Nov 17, 2025
Start date
Nov 24, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
121 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 2: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 3: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 4: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 5: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 6: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 7: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.
  • Experimental: Group 8: ABBV-547 & Placebo
    Japanese participants will receive either ABBV-547 or placebo.
  • Experimental: Group 9: ABBV-547 & Placebo
    Han Chinese participants will receive either ABBV-547 or placebo.
  • Experimental: Group 10: ABBV-547 & Placebo
    Participants will receive either ABBV-547 or placebo.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Approximately Day 365 ]

Central Contacts

Locations (21)

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