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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of the Ryukyus Hospital /ID# 279918, Ginowan-shi, Okinawa, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-547

Drug

Parental Administration

ABBV-547 Placebo

Drug

Parental Administration

Primary outcomes

Number of Participants with Adverse Events (AEs)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Nov 17, 2025
Registry last updated: Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting