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 Anaheim, California.
- 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
- ABBV-547 — DRUGInjection
- ABBV-547 Placebo — DRUGInjection
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 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.
Key Dates
- Start date
- Nov 24, 2025
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 87 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1: ABBV-547 & PlaceboParticipants will receive either ABBV-547 or placebo.
- Experimental: Group 2: ABBV-547 & PlaceboParticipants will receive either ABBV-547 or placebo.
- Experimental: Group 3: ABBV-547 & PlaceboParticipants will receive either ABBV-547 or placebo.
- Experimental: Group 4: ABBV-547 & PlaceboParticipants will receive either ABBV-547 or placebo.
- Experimental: Group 5: ABBV-547 & PlaceboParticipants will receive either ABBV-547 or placebo.
- Experimental: Group 6: ABBV-547 & PlaceboParticipants 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
- ABBVIE CALL CENTER844-663-3742
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 279612 | Anaheim | California | 92801 | - |
| Acpru /Id# 278638 | Grayslake | Illinois | 60030 | - |
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