A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections (NCT07232004)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Total Dermatology /ID# 279798 โ Birmingham, Alabama
Age range: 18 Years to 55 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (23 Sites)
- Total Dermatology /ID# 279798 โ Birmingham, Alabama
- Dermatology Trial Associates /ID# 279984 โ Bryant, Arkansas
- CenExel ACT- Anaheim Clinical Trials /ID# 279612 โ Anaheim, California
- Dermatology Research Associates - Los Angeles /ID# 279383 โ Los Angeles, California
- Integrative Skin Science and Research - Location 2 /ID# 279386 โ Sacramento, California
- Skin Care Research Boca Raton /ID# 279988 โ Boca Raton, Florida
- Wellness Clinical Research - Miami Lakes /ID# 279803 โ Miami Lakes, Florida
- Advanced Clinical Research Institute - Tampa /ID# 279342 โ Tampa, Florida
- Trueblue Clinical Research - Tampa /ID# 281757 โ Tampa, Florida
- University Dermatology & Vein Clinic - Darien /ID# 279986 โ Darien, Illinois
- Acpru /Id# 278638 โ Grayslake, Illinois
- MetroBoston Clinical Partners /ID# 279992 โ Boston, Massachusetts
- Minnesota Clinical Study Center /ID# 279987 โ New Brighton, Minnesota
- MediSearch Clinical Trials /ID# 279416 โ Saint Joseph, Missouri
- Skin Specialists /ID# 279531 โ Omaha, Nebraska
- The Skin Center Dermatology Group /ID# 279983 โ New City, New York
- Equity Medical, LLC - Bronx /ID# 279808 โ The Bronx, New York
- Oregon Dermatology and Research Center /ID# 279391 โ Portland, Oregon
- Health Concepts /ID# 279529 โ Rapid City, South Dakota
- Center for Clinical Studies - Houston - Binz Street /ID# 279419 โ Houston, Texas
- Austin Institute for Clinical Research - Pflugerville /ID# 279387 โ Pflugerville, Texas
- University of the Ryukyus Hospital /ID# 279918 โ Ginowan-shi, Okinawa
- Fukuoka University Hospital /ID# 279530 โ Fukuoka,
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.