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RECRUITING
NCT07232004
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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 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.

Official title: A First-in-Human, Phase 1a/b, Single-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 - 55 Years

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2025-11-24

Completion Date

2027-08

Last Updated

2026-06-17

Healthy Volunteers

Yes

Interventions

DRUG

ABBV-547

Parental Administration

DRUG

ABBV-547 Placebo

Parental Administration

Locations (23)

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

Skin Care Research Boca Raton /ID# 279988

Boca Raton, Florida, 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

Trueblue Clinical Research - Tampa /ID# 281757

Tampa, Florida, United States

University Dermatology & Vein Clinic - Darien /ID# 279986

Darien, Illinois, 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 & 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