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ABBV-1042

Phase 1

Undisclosed | Small molecule | Other |AbbVie Inc.|Trials Updated: Oct 15, 2026

ABBV-1042 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

ABBV-1042 clinical trials

ABBV-1042 · 1 trial · 1 indication

Phase 1 1
NCT07222709A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult ParticipantsHealthy Volunteer
COMPLETED36 Analytics
PHASE1COMPLETED
A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Adverse Events
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.

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

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

Number of Participants with Abnormal Change in Physical Examinations
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.

Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Up to approximately 3 days

12-lead resting ECG will be recorded.

Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Up to approximately 3 days

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

Maximum Plasma Concentration (Cmax) of ABBV-1042
Up to approximately 3 days

Cmax of ABBV-1042

Time to Cmax (Tmax) of ABBV-1042
Up to approximately 3 days

Tmax of ABBV-1042

Apparent terminal phase elimination constant (β) of ABBV-1042
Up to approximately 3 days

β of ABBV-1042

Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042
Up to approximately 3 days

t1/2 of ABBV-1042

Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042
Up to approximately 3 days

AUCt of ABBV-1042

Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042
Up to approximately 3 days

AUCinf of ABBV-1042

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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ABBV-1042 or Placebo-Group 1EXPERIMENTALParticipants will receive an oral dose of ABBV-1042 or placebo on day 1.
ABBV-1042 or Placebo-Group 2EXPERIMENTALParticipants will receive an oral dose of ABBV-1042 or placebo on day 1.
ABBV-1042 or Placebo-Group 3EXPERIMENTALParticipants will receive an oral dose of ABBV-1042 or placebo on day 1.
ABBV-1042 or Placebo-Group 4EXPERIMENTALParticipants will receive an oral dose of ABBV-1042 or placebo on day 1.
ABBV-1042 or Placebo-Group 5EXPERIMENTALParticipants will receive an oral dose of ABBV-1042 or placebo on day 1.
ABBV-1042 or Placebo-Group 6EXPERIMENTALParticipants will receive an oral dose of ABBV-1042 or placebo on day 1.

Interventions

NameTypeDescription
ABBV-1042DRUGOral Solution
PlaceboDRUGOral Solution
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 hea...

Countries:United States
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Recent Changes (Last 90 Days)

HIGHOct 15, 2026NCT07222709Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHOct 15, 2026NCT07222709Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWOct 8, 2026NCT07222709primaryCompletionDate: changed
LOWOct 8, 2026NCT07222709primaryCompletionDate: changed
MEDIUMSep 22, 2026NCT07222709Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMSep 22, 2026NCT07222709Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about ABBV-1042

What is ABBV-1042?

ABBV-1042 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV). It is in Phase 1 clinical development, and the specific disease or condition it is intended to treat has not been publicly disclosed. The only completed study of ABBV-1042 enrolled healthy adult volunteers rather than patients.

Who makes ABBV-1042?

ABBV-1042 is made by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the developer and sponsor of the compound's clinical program. ABBV-1042 is an early-stage small molecule asset in the company's pipeline.

What phase is ABBV-1042 in?

ABBV-1042 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials of ABBV-1042 are currently listed. The compound is investigational and has not been established as a marketed or approved therapy.

What clinical trials is ABBV-1042 in?

ABBV-1042 has been studied in one completed Phase 1 trial, NCT07222709, titled a study to assess adverse events and how oral ABBV-1042 moves through the body of healthy adult participants. The trial enrolled 36 healthy volunteers in the United States, was randomized, double-blind, and controlled, and included participants aged 18 years and older of all sexes.

What is known about the ABBV-1042 Phase 1 trial design?

The completed Phase 1 study of ABBV-1042, NCT07222709, was a randomized, double-blind, controlled trial in 36 healthy adult volunteers in the United States. It assessed adverse events and how oral ABBV-1042 moves through the body. Participants were 18 years or older and of all sexes, and the study was not biomarker selected.