Recruiting
Phase 1

ABBV-1042

Sponsor:

AbbVie

Code:

NCT07222709

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

ABBV-1042

Placebo

Study Details

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

Study ID

NCT07222709

Start date

Oct 27, 2025

Status verified date

Oct, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: ABBV-1042 or Placebo-Group 1

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

experimental: ABBV-1042 or Placebo-Group 2

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

experimental: ABBV-1042 or Placebo-Group 3

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

experimental: ABBV-1042 or Placebo-Group 4

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

experimental: ABBV-1042 or Placebo-Group 5

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

experimental: ABBV-1042 or Placebo-Group 6

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

Interventions

ABBV-1042

Oral Solution

Placebo

Oral Solution

Primary outcome measure

  • Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 32 days ]
  • Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [ Time Frame: Up to approximately 3 days ]
  • Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to approximately 3 days ]
  • Number of Participants with Abnormal Change in Physical Examinations [ Time Frame: Up to approximately 3 days ]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Up to approximately 3 days ]
  • Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [ Time Frame: Up to approximately 3 days ]
  • Maximum Plasma Concentration (Cmax) of ABBV-1042 [ Time Frame: Up to approximately 3 days ]
  • Time to Cmax (Tmax) of ABBV-1042 [ Time Frame: Up to approximately 3 days ]
  • Apparent terminal phase elimination constant (β) of ABBV-1042 [ Time Frame: Up to approximately 3 days ]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042 [ Time Frame: Up to approximately 3 days ]
  • 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 ]
  • Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042 [ Time Frame: Up to approximately 3 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Acpru /Id# 279405

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Healthy Volunteer
  • ABBV-1042

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2025-10-30.