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Active, not recruitingNCT07222709Updated Sep 22, 2026

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

A Phase 1 interventional study of ABBV-1042 and Placebo in Healthy Volunteer, sponsored by AbbVie. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
  • ABBV-1042
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    ABBV-1042 or Placebo-Group 1

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

    Drug: ABBV-1042 · Drug: Placebo

  • Experimental
    ABBV-1042 or Placebo-Group 2

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

    Drug: ABBV-1042 · Drug: Placebo

  • Experimental
    ABBV-1042 or Placebo-Group 3

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

    Drug: ABBV-1042 · Drug: Placebo

  • Experimental
    ABBV-1042 or Placebo-Group 4

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

    Drug: ABBV-1042 · Drug: Placebo

  • Experimental
    ABBV-1042 or Placebo-Group 5

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

    Drug: ABBV-1042 · Drug: Placebo

  • Experimental
    ABBV-1042 or Placebo-Group 6

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

    Drug: ABBV-1042 · Drug: Placebo

Interventions

  • DrugABBV-1042

    Oral Solution

  • DrugPlacebo

    Oral Solution

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 32 days

  2. 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.

    Time frame: Up to approximately 3 days

  3. 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.

    Time frame: Up to approximately 3 days

  4. 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.

    Time frame: Up to approximately 3 days

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

    12-lead resting ECG will be recorded.

    Time frame: Up to approximately 3 days

  6. 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.

    Time frame: Up to approximately 3 days

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

    Cmax of ABBV-1042

    Time frame: Up to approximately 3 days

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

    Tmax of ABBV-1042

    Time frame: Up to approximately 3 days

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

    β of ABBV-1042

    Time frame: Up to approximately 3 days

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

    t1/2 of ABBV-1042

    Time frame: Up to approximately 3 days

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

    AUCt of ABBV-1042

    Time frame: Up to approximately 3 days

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

    AUCinf of ABBV-1042

    Time frame: Up to approximately 3 days

07

Study locations

1 site
  • Acpru /Id# 279405
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07222709
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Oct 30, 2025
Start date
Oct 27, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Sep 22, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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