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ABBV-1042

Phase 1

Healthy Volunteer | Small molecule | Other |AbbVie Inc.|Last Updated: Oct 30, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

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
RECRUITING48 Analytics
PHASE1RECRUITING
A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants
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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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Frequently asked questions about ABBV-1042

What is ABBV-1042 used for?

ABBV-1042 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a trial assessing adverse events and how the drug moves through the body of healthy adult participants. It is not approved for any condition and remains in early-stage clinical testing.

Who makes ABBV-1042?

ABBV-1042 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 study of this oral small molecule in healthy volunteers in the United States.

What phase is ABBV-1042 in?

ABBV-1042 is in Phase 1 clinical development. The ongoing trial is recruiting healthy adult participants in the United States to evaluate adverse events and how the oral drug moves through the body. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is ABBV-1042 in?

ABBV-1042 is being studied in one active Phase 1 clinical trial, identified as NCT07222709. This randomized, double-blind, controlled study is recruiting 48 healthy adult participants in the United States to assess adverse events and how oral ABBV-1042 moves through the body.

Is ABBV-1042 a small molecule?

Yes, ABBV-1042 is a small molecule drug. It is being developed as an oral formulation and is currently in a Phase 1 study involving healthy volunteers to evaluate its safety and pharmacokinetics. The trial is randomized, double-blind, and controlled.