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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
Are there results?
Not yet: the study is under way

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.

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.

Read more

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.

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 groupRoleWhat they receive
Group 1: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 2: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 3: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 4: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 5: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 6: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 7: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 8: ABBV-547 & PlaceboExperimentalJapanese participants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 9: ABBV-547 & PlaceboExperimentalHan Chinese participants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 10: ABBV-547 & PlaceboExperimentalParticipants will receive either ABBV-547 or placebo.
Receives: Drug: ABBV-547; Drug: ABBV-547 Placebo
Group 11: ABBV-547 & PlaceboExperimentalParticipants 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.

  1. 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.

  1. First posted17 Nov 2025
  2. Study start24 Nov 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) (time frame: Up to Approximately Day 365). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07232004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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