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A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants

NCT ID: NCT07222709

Last Updated: 2025-10-30

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2026-05-31

Brief Summary

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This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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Healthy Volunteer ABBV-1042

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ABBV-1042 or Placebo-Group 1

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group Type EXPERIMENTAL

ABBV-1042

Intervention Type DRUG

Oral Solution

Placebo

Intervention Type DRUG

Oral Solution

ABBV-1042 or Placebo-Group 2

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group Type EXPERIMENTAL

ABBV-1042

Intervention Type DRUG

Oral Solution

Placebo

Intervention Type DRUG

Oral Solution

ABBV-1042 or Placebo-Group 3

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group Type EXPERIMENTAL

ABBV-1042

Intervention Type DRUG

Oral Solution

Placebo

Intervention Type DRUG

Oral Solution

ABBV-1042 or Placebo-Group 4

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group Type EXPERIMENTAL

ABBV-1042

Intervention Type DRUG

Oral Solution

Placebo

Intervention Type DRUG

Oral Solution

ABBV-1042 or Placebo-Group 5

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group Type EXPERIMENTAL

ABBV-1042

Intervention Type DRUG

Oral Solution

Placebo

Intervention Type DRUG

Oral Solution

ABBV-1042 or Placebo-Group 6

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group Type EXPERIMENTAL

ABBV-1042

Intervention Type DRUG

Oral Solution

Placebo

Intervention Type DRUG

Oral Solution

Interventions

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ABBV-1042

Oral Solution

Intervention Type DRUG

Placebo

Oral Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight ˃ 45 kg at the time of screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria

* History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
* Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.
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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Acpru /Id# 279405

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=M25-818

Related Info

Other Identifiers

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M25-818

Identifier Type: -

Identifier Source: org_study_id