Healthy VolunteerPhase 1NCT07232004

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

A Phase 1 study testing ABBV-547 in people with Healthy Volunteer and Psoriasis, run by AbbVie at 20 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer, Psoriasis
What is being tested?: ABBV-547
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 20 sitesin 2 countries
Study dates: 24 Nov 2025to May 2028
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

20 sites in 2 countries.

Country

City, postcode or hospital

20 sites in 2 countries

United States18 sites

CenExel Act- Anaheim Clinical Trials /ID# 279612
Anaheim, California, 92801
Total Dermatology /ID# 279798
Birmingham, Alabama, 35203-4024
MetroBoston Clinical Partners /ID# 279992
Boston, Massachusetts, 02135
Dermatology Trial Associates /ID# 279984
Bryant, Arkansas, 72022
Acpru /Id# 278638
Grayslake, Illinois, 60030
Center for Clinical Studies - Houston - Binz Street /ID# 279419
Houston, Texas, 77004
Dermatology Research Associates - Los Angeles /ID# 279383
Los Angeles, California, 90045
Wellness Clinical Research - Miami Lakes /ID# 279803
Miami Lakes, Florida, 33016
Minnesota Clinical Study Center /ID# 279987
New Brighton, Minnesota, 55112
The Skin Center Dermatology Group. /ID# 279983
New City, New York, 10956-7153
Skin Specialists /ID# 279531
Omaha, Nebraska, 68144
Austin Institute for Clinical Research - Pflugerville /ID# 279387
Pflugerville, Texas, 78660
Oregon Dermatology and Research Center /ID# 279391
Portland, Oregon, 97210
Health Concepts /ID# 279529
Rapid City, South Dakota, 57702
Integrative Skin Science and Research - Location 2 /ID# 279386
Sacramento, California, 95815
MediSearch Clinical Trials /ID# 279416
Saint Joseph, Missouri, 64506
Advanced Clinical Research Institute - Tampa /ID# 279342
Tampa, Florida, 33607
Equity Medical, LLC - Bronx /ID# 279808
The Bronx, New York, 10455

Other trials in United States

Japan2 sites

Fukuoka University Hospital /ID# 279530
Fukuoka, 814-0180
University of the Ryukyus Hospital /ID# 279918
Ginowan-shi, Okinawa, 901-2725

Other trials in Japan

About this study

Official title: A First-in-Human, Phase 1a/b, Single-Dose and Multiple-Dose Study of ABBV-547 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Adult Participants and Efficacy in Adult Participants

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.

Conditions: Healthy Volunteer, Psoriasis
Being tested: ABBV-547, ABBV-547 Placebo
Keywords: Healthy Volunteer, ABBV-547
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABBV-547Drug
Parental Administration
ABBV-547 PlaceboDrug
Parental Administration

Study groups in NCT07232004
Study group	Role	What they receive
Group 1: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 2: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 3: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 4: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 5: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 6: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 7: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 8: ABBV-547 & Placebo	Experimental	Japanese participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 9: ABBV-547 & Placebo	Experimental	Han Chinese participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 10: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 11: ABBV-547 & Placebo	Experimental	Participants will receive either ABBV-547 or placebo. Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants with Adverse Events (AEs)
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.
Measured: Up to Approximately Day 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 2025May 2028

First posted17 Nov 2025
Study start24 Nov 2025
Primary completionMay 2028 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 142 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07232004
Sponsor's protocol ID: M26-058
Status last verified: Oct 2026
First submitted: 14 Nov 2025
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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