Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07222709

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 279405

Grayslake, Illinois, 60030, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-1042

Drug

Oral Solution

Placebo

Drug

Oral Solution

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 32 days

    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.

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

    Time frame: Up to approximately 3 days

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

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

    Time frame: Up to approximately 3 days

    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.

  4. Number of Participants with Abnormal Change in Physical Examinations

    Time frame: Up to approximately 3 days

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

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

    Time frame: Up to approximately 3 days

    12-lead resting ECG will be recorded.

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

    Time frame: Up to approximately 3 days

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

  7. Maximum Plasma Concentration (Cmax) of ABBV-1042

    Time frame: Up to approximately 3 days

    Cmax of ABBV-1042

  8. Time to Cmax (Tmax) of ABBV-1042

    Time frame: Up to approximately 3 days

    Tmax of ABBV-1042

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

    Time frame: Up to approximately 3 days

    β of ABBV-1042

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

    Time frame: Up to approximately 3 days

    t1/2 of ABBV-1042

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

    Time frame: Up to approximately 3 days

    AUCt of ABBV-1042

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

    Time frame: Up to approximately 3 days

    AUCinf of ABBV-1042

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.