A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
Condition(s) studied
Investigational drug(s) / intervention(s)
ABBV-547: Parental Administration
ABBV-547 Placebo: Parental Administration
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) — Up to Approximately Day 365
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| Total Dermatology /ID# 279798 | Birmingham | Alabama | |
| Dermatology Trial Associates /ID# 279984 | Bryant | Arkansas | |
| CenExel Act- Anaheim Clinical Trials /ID# 279612 | Anaheim | California | |
| Dermatology Research Associates - Los Angeles /ID# 279383 | Los Angeles | California | |
| Integrative Skin Science and Research - Location 2 /ID# 279386 | Sacramento | California | |
| Wellness Clinical Research - Miami Lakes /ID# 279803 | Miami Lakes | Florida | |
| Advanced Clinical Research Institute - Tampa /ID# 279342 | Tampa | Florida | |
| Acpru /Id# 278638 | Grayslake | Illinois | |
| MetroBoston Clinical Partners /ID# 279992 | Boston | Massachusetts | |
| Minnesota Clinical Study Center /ID# 279987 | New Brighton | Minnesota | |
| MediSearch Clinical Trials /ID# 279416 | Saint Joseph | Missouri | |
| Skin Specialists /ID# 279531 | Omaha | Nebraska | |
| The Skin Center Dermatology Group. /ID# 279983 | New City | New York | |
| Equity Medical, LLC - Bronx /ID# 279808 | The Bronx | New York | |
| Oregon Dermatology and Research Center /ID# 279391 | Portland | Oregon | |
| Health Concepts /ID# 279529 | Rapid City | South Dakota | |
| Center for Clinical Studies - Houston - Binz Street /ID# 279419 | Houston | Texas | |
| Austin Institute for Clinical Research - Pflugerville /ID# 279387 | Pflugerville | Texas | |
| University of the Ryukyus Hospital /ID# 279918 | Ginowan-shi | Okinawa | |
| Fukuoka University Hospital /ID# 279530 | Fukuoka | Japan |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07232004 on ClinicalTrials.gov ↗ ← All trials in the USA