Study to Assess Adverse Events and How Oral ABBV-1162 Moves Through the Body of Healthy Adults

September 16, 2026 updated by: AbbVie

A Phase 1, Double-blind, Placebo-Controlled, First-in-Human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses ofABBV-1162 in Healthy Subjects

The goal of this study is to evaluate the safety, tolerability, and pharmacokinetics of ABBV-1162 in healthy adults.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy individuals in general good health.
  • Blood pressure and heart rate measurements within specified ranges: systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, heart rate <= 100 bpm and >= 55 bpm, absence of orthostatic hypotension.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-1162

Participants will receive a single oral dose of ABBV-1162.
Drug: ABBV-1162

Oral
Placebo Comparator: Placebo

Participants will receive a single oral dose of placebo.
Drug: Placebo

Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events
Time Frame: Up to approximately 31 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.
Up to approximately 31 days
Maximum Plasma Concentration (Cmax) of ABBV-1162
Time Frame: Up to approximately 3 days

Cmax of ABBV-1162
Up to approximately 3 days
Time to Cmax (Tmax) of ABBV-1162
Time Frame: Up to approximately 3 days

Time to Cmax (Tmax) of ABBV-1162
Up to approximately 3 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1162
Time Frame: Up to approximately 3 days

Beta of ABBV-1162
Up to approximately 3 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1162
Time Frame: Up to approximately 3 days

t1/2 of ABBV-1162
Up to approximately 3 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-1162
Time Frame: Up to approximately 3 days

AUCt of ABBV-1162
Up to approximately 3 days
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-1162
Time Frame: Up to approximately 3 days

AUCinf of ABBV-1162
Up to approximately 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

September 16, 2026

First Submitted That Met QC Criteria

September 16, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 22, 2026

Last Update Submitted That Met QC Criteria

September 16, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M26-187

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

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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