Recruiting

ABBV-8736 Safety and Tolerability in Healthy Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

ABBV-8736

+ Placebo
Drug
Who is being recruted

Healthy Volunteer

From 18 to 55 Years
+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled
Phase 1
Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorAbbVie
Study ContactABBVIE CALL CENTER
Last updated: September 12, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 2, 2025Actual 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: September 12, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Healthy Volunteer
Criteria
2 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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
Placebo
Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses.
Group III
Experimental
Participants will receive IV ABBV-8736 dose B 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

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Cmax of ABBV-8736.

Tmax of ABBV-8736.

AUCtau of ABBV-8736.

Ctrough of ABBV-8736.

β of ABBV-8736.

t1/2 of ABBV-8736.

CL for IV dosing.

Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.

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# 277377Grayslake, United StatesSee the location
Recruiting
One Study Center