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Active, not recruiting Phase 1

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

NCT07232004 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Phase 1
Started
2025-11-24
Last updated
2026-10-15

Condition(s) studied

Healthy VolunteerPsoriasis

Investigational drug(s) / intervention(s)

ABBV-547ABBV-547 Placebo

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG). * Part 1: BMI is \>= 18.0 to \<= 29.9 kg/m\^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Part 2: must have discontinued use of phototherapy (e.g., UVA or UVB) at least 2 weeks prior to the baseline visit (Day 1) and PUVA phototherapy at least 4 weeks prior to the baseline visit (Day 1). Exclusion Criteria: * History of any clinically significant sensitivity or allergy to any medication or food. * Part 2: uses any herbal supplements within the 2-week period prior to study treatment administration. * Part 2: received any biologics including investigational agents within 2.5 half-lives prior to Baseline.

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)

FacilityCityRegionStatus
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
Official registry record

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