Recruiting

ABBV-8736 Safety and Tolerability in Healthy Adults

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What is being tested

ABBV-8736

+ Placebo

Drug
Who is being recruted

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: September 2, 2025

Actual date on which the first participant was enrolled.

This study aims to explore how a new drug called ABBV-8736 behaves in the body and how the immune system responds to it. It is conducted with healthy adults to ensure the safety of the drug before it is tested in patients with specific conditions. This research is crucial in determining the initial safety and appropriate dosage levels, which is a foundational step in the development of new medications that may eventually help treat various diseases. Participants in this study receive the drug ABBV-8736 through an intravenous (IV) method, which means it is administered directly into the bloodstream. The study examines different doses to see how well participants tolerate the drug and to check for any adverse effects. The effects of the drug are closely monitored, including how it is processed by the body and whether it triggers any immune response. This data helps researchers understand the potential risks and benefits, laying the groundwork for future studies with patients who may benefit from the medication.

Official TitleA Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-8736 After Multiple Ascending Doses in Healthy Adult Subjects 
Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Body mass index (BMI) is \>= 18.0 to \<= 32.0 kg/m\^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * History of any clinically significant sensitivity or allergy to any medication or food. * Prior exposure to a TREM1 agent.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses.

Group II

Experimental
Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses.

Group III

Placebo
Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses.

Group IV

Placebo
Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Acpru /Id# 277377

Grayslake, United StatesSee the location
Recruiting
One Study Center