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A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
Sponsor: AbbVie
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 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 4 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Group 11 is the only group that will receive multiple doses. Approximately 142 adult participants will be enrolled at approximately 21 sites in the United States and Japan. Participants will be administered one dose or multiple doses 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.
Official title: A First-in-Human, Phase 1a/b, Single-Dose and Multiple-Dose Study of ABBV-547 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Adult Participants and Efficacy in Adult Participants
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2025-11-24
Completion Date
2028-05
Last Updated
2026-10-15
Healthy Volunteers
Yes
Conditions
Interventions
ABBV-547
Parental Administration
ABBV-547 Placebo
Parental Administration
Locations (20)
Total Dermatology /ID# 279798
Birmingham, Alabama, United States
Dermatology Trial Associates /ID# 279984
Bryant, Arkansas, United States
CenExel Act- Anaheim Clinical Trials /ID# 279612
Anaheim, California, United States
Dermatology Research Associates - Los Angeles /ID# 279383
Los Angeles, California, United States
Integrative Skin Science and Research - Location 2 /ID# 279386
Sacramento, California, United States
Wellness Clinical Research - Miami Lakes /ID# 279803
Miami Lakes, Florida, United States
Advanced Clinical Research Institute - Tampa /ID# 279342
Tampa, Florida, United States
Acpru /Id# 278638
Grayslake, Illinois, United States
MetroBoston Clinical Partners /ID# 279992
Boston, Massachusetts, United States
Minnesota Clinical Study Center /ID# 279987
New Brighton, Minnesota, United States
MediSearch Clinical Trials /ID# 279416
Saint Joseph, Missouri, United States
Skin Specialists /ID# 279531
Omaha, Nebraska, United States
The Skin Center Dermatology Group. /ID# 279983
New City, New York, United States
Equity Medical, LLC - Bronx /ID# 279808
The Bronx, New York, United States
Oregon Dermatology and Research Center /ID# 279391
Portland, Oregon, United States
Health Concepts /ID# 279529
Rapid City, South Dakota, United States
Center for Clinical Studies - Houston - Binz Street /ID# 279419
Houston, Texas, United States
Austin Institute for Clinical Research - Pflugerville /ID# 279387
Pflugerville, Texas, United States
University of the Ryukyus Hospital /ID# 279918
Ginowan-shi, Okinawa, Japan
Fukuoka University Hospital /ID# 279530
Fukuoka, Japan