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

NCT07222709 | Recruiting Phase 1

• 1 other identifier: M25-818
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-1042

Outcome Measures

Primary Outcomes (12)

• Number of Participants Experiencing Adverse Events

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to approximately 32 days

• Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

  Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  Up to approximately 3 days

• Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

  The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.

  Up to approximately 3 days

• Number of Participants with Abnormal Change in Physical Examinations

  Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, and neurological systems will be assessed.

  Up to approximately 3 days

• Number of Participants with Change from Baseline in Electrocardiogram (ECG)

  12-lead resting ECG will be recorded.

  Up to approximately 3 days

• Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

  Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.

  Up to approximately 3 days

• Maximum Plasma Concentration (Cmax) of ABBV-1042

  Cmax of ABBV-1042

  Up to approximately 3 days

• Time to Cmax (Tmax) of ABBV-1042

  Tmax of ABBV-1042

  Up to approximately 3 days

• Apparent terminal phase elimination constant (β) of ABBV-1042

  β of ABBV-1042

  Up to approximately 3 days

• Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042

  t1/2 of ABBV-1042

  Up to approximately 3 days

• Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042

  AUCt of ABBV-1042

  Up to approximately 3 days

• Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042

  AUCinf of ABBV-1042

  Up to approximately 3 days

Study Arms (6)

ABBV-1042 or Placebo-Group 1

EXPERIMENTAL

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

Drug: ABBV-1042; Drug: Placebo

ABBV-1042 or Placebo-Group 2

EXPERIMENTAL

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

Drug: ABBV-1042; Drug: Placebo

ABBV-1042 or Placebo-Group 3

EXPERIMENTAL

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

Drug: ABBV-1042; Drug: Placebo

ABBV-1042 or Placebo-Group 4

EXPERIMENTAL

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

Drug: ABBV-1042; Drug: Placebo

ABBV-1042 or Placebo-Group 5

EXPERIMENTAL

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

Drug: ABBV-1042; Drug: Placebo

ABBV-1042 or Placebo-Group 6

EXPERIMENTAL

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

Drug: ABBV-1042; Drug: Placebo

Interventions

ABBV-1042 DRUG

Oral Solution

ABBV-1042 or Placebo-Group 1; ABBV-1042 or Placebo-Group 2; ABBV-1042 or Placebo-Group 3; ABBV-1042 or Placebo-Group 4; ABBV-1042 or Placebo-Group 5; ABBV-1042 or Placebo-Group 6

Placebo DRUG

Oral Solution

ABBV-1042 or Placebo-Group 1; ABBV-1042 or Placebo-Group 2; ABBV-1042 or Placebo-Group 3; ABBV-1042 or Placebo-Group 4; ABBV-1042 or Placebo-Group 5; ABBV-1042 or Placebo-Group 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 279405

Grayslake, Illinois, 60030, United States

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 30, 2025
• Study Start: October 27, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)