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

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: ABBV-1042

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 279405

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABBV-1042 or Placebo-Group 1; Participants will receive an oral dose of ABBV-1042 or placebo on day 1.	Drug: Placebo; Oral Solution; Drug: ABBV-1042; Oral Solution
Experimental: ABBV-1042 or Placebo-Group 2; Participants will receive an oral dose of ABBV-1042 or placebo on day 1.	Drug: Placebo; Oral Solution; Drug: ABBV-1042; Oral Solution
Experimental: ABBV-1042 or Placebo-Group 3; Participants will receive an oral dose of ABBV-1042 or placebo on day 1.	Drug: Placebo; Oral Solution; Drug: ABBV-1042; Oral Solution
Experimental: ABBV-1042 or Placebo-Group 4; Participants will receive an oral dose of ABBV-1042 or placebo on day 1.	Drug: Placebo; Oral Solution; Drug: ABBV-1042; Oral Solution
Experimental: ABBV-1042 or Placebo-Group 5; Participants will receive an oral dose of ABBV-1042 or placebo on day 1.	Drug: Placebo; Oral Solution; Drug: ABBV-1042; Oral Solution
Experimental: ABBV-1042 or Placebo-Group 6; Participants will receive an oral dose of ABBV-1042 or placebo on day 1.	Drug: Placebo; Oral Solution; Drug: ABBV-1042; Oral Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to approximately 32 days
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.	Up to approximately 3 days
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.	Up to approximately 3 days
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.	Up to approximately 3 days
Number of Participants with Change from Baseline in Electrocardiogram (ECG)	12-lead resting ECG will be recorded.	Up to approximately 3 days
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.	Up to approximately 3 days
Maximum Plasma Concentration (Cmax) of ABBV-1042	Cmax of ABBV-1042	Up to approximately 3 days
Time to Cmax (Tmax) of ABBV-1042	Tmax of ABBV-1042	Up to approximately 3 days
Apparent terminal phase elimination constant (β) of ABBV-1042	β of ABBV-1042	Up to approximately 3 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042	t1/2 of ABBV-1042	Up to approximately 3 days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042	AUCt of ABBV-1042	Up to approximately 3 days
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042	AUCinf of ABBV-1042	Up to approximately 3 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-1042
• Other Study ID Numbers: M25-818

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No