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

NCT ID: NCT07232004

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2027-09-30

Brief Summary

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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 3 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 87 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.

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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Healthy Volunteer ABBV-547

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1: ABBV-547 & Placebo

Participants will receive either ABBV-547 or placebo.

Group Type EXPERIMENTAL

ABBV-547

Intervention Type DRUG

Injection

ABBV-547 Placebo

Intervention Type DRUG

Injection

Group 2: ABBV-547 & Placebo

Participants will receive either ABBV-547 or placebo.

Group Type EXPERIMENTAL

ABBV-547

Intervention Type DRUG

Injection

ABBV-547 Placebo

Intervention Type DRUG

Injection

Group 3: ABBV-547 & Placebo

Participants will receive either ABBV-547 or placebo.

Group Type EXPERIMENTAL

ABBV-547

Intervention Type DRUG

Injection

ABBV-547 Placebo

Intervention Type DRUG

Injection

Group 4: ABBV-547 & Placebo

Participants will receive either ABBV-547 or placebo.

Group Type EXPERIMENTAL

ABBV-547

Intervention Type DRUG

Injection

ABBV-547 Placebo

Intervention Type DRUG

Injection

Group 5: ABBV-547 & Placebo

Participants will receive either ABBV-547 or placebo.

Group Type EXPERIMENTAL

ABBV-547

Intervention Type DRUG

Injection

ABBV-547 Placebo

Intervention Type DRUG

Injection

Group 6: ABBV-547 & Placebo

Participants will receive either ABBV-547 or placebo.

Group Type EXPERIMENTAL

ABBV-547

Intervention Type DRUG

Injection

ABBV-547 Placebo

Intervention Type DRUG

Injection

Interventions

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ABBV-547

Injection

Intervention Type DRUG

ABBV-547 Placebo

Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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CenExel ACT- Anaheim Clinical Trials /ID# 279612

Anaheim, California, United States

Site Status RECRUITING

Acpru /Id# 278638

Grayslake, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M26-058

Related Info

Other Identifiers

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M26-058

Identifier Type: -

Identifier Source: org_study_id