ABBV-8736 for Healthy Volunteers

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiac, Respiratory, others

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new drug, ABBV-8736, in healthy adults. Researchers seek to understand how the body processes different doses of the drug, administered through an IV (intravenous, meaning directly into a vein) every two weeks. Participants will receive either the drug or a placebo, a harmless substance that resembles the drug but has no effect. This trial is ideal for individuals in good health without significant medical conditions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that ABBV-8736 is likely to be safe for humans?

Earlier studies tested ABBV-8736 with healthy volunteers to determine the frequency and severity of side effects. These studies provide insights into the drug's safety and how the body processes it. As a Phase 1 trial, ABBV-8736 is being tested in humans for the first time. The goal is to assess the drug's safety and tolerability.

Specific information about side effects from earlier research on ABBV-8736 is not available. However, the trial's focus on healthy adults indicates that researchers prioritize safety and tolerability. ABBV-8736 has not been approved for other uses, so this trial is crucial for understanding its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABBV-8736 because it offers a new approach to treatment through its unique delivery method and potential mechanism of action. Unlike most standard treatments, which are often administered orally or through subcutaneous injections, ABBV-8736 is given intravenously, potentially allowing for more direct and controlled dosing. Additionally, this drug might work differently by targeting specific pathways or mechanisms that current therapies don't address, although the exact details are still being explored. This innovative approach could lead to more effective and faster results for patients, setting it apart from existing options.

What evidence suggests that ABBV-8736 could be effective?

Researchers are studying ABBV-8736, a new drug, to assess its safety and how it functions in the body. In this trial with healthy volunteers, they are examining the drug's processing by the body and the immune system's response. Participants will receive either Dose A or Dose B of ABBV-8736, or a placebo. Currently, there is no information on its effectiveness for any specific condition, as the research remains in its early stages. The main goal is to determine if people can take it without major side effects and to understand its movement and action in the body. This step is crucial before testing it for specific illnesses. ^{1 3 4 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to understand the safety and body's response to multiple doses of ABBV-8736. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am in good health overall, as confirmed by recent medical exams.

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.

Exclusion Criteria

I have been treated with a TREM1 agent before.

History of any clinically significant sensitivity or allergy to any medication or food.

I do not have any significant ongoing health issues like heart, lung (except mild childhood asthma), kidney, liver, stomach, blood, mental health problems, or uncontrolled illnesses.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) ABBV-8736 or placebo every 2 weeks for a total of 3 doses

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and immunogenicity after treatment

Up to approximately 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-8736

Trial Overview The trial is testing how safe ABBV-8736 is when given through IV and how it moves through and out of the body. Some people will get ABBV-8736, while others will get a placebo (a treatment with no active drug).

How Is the Trial Designed?

Group I: Group 2: Dose B of ABBV-8736 Experimental Treatment 1 Intervention

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

Group II: Group 1: Dose A of ABBV-8736 Experimental Treatment 1 Intervention

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

Group III: Group 1: Dose A of ABBV-8736 Placebo Placebo Group 1 Intervention

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

Group IV: Group 2: Dose B of ABBV-8736 Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07141199

NCT07141199 | A Study to Evaluate Adverse Events, How ... The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ...

2. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/34670174/abbvies-new-phase-1-study-a-closer-look-at-abbv-8736/

AbbVie's New Phase 1 Study: A Closer Look at ABBV-8736 ' The study aims to assess the safety and tolerability of ABBV-8736, an intravenous drug, in healthy volunteers. This research is ...

3. patlynk.com patlynk.com/trial/NCT07141199

ABBV-8736 Safety and Tolerability in Healthy Adults 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 ...

4. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2025-de3f4

ABBV-8736 for Healthy Volunteers This Phase 1 medical study run by AbbVie is evaluating whether ABBV-8736 will have tolerable side effects & efficacy for patients with Healthy Subjects.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39102457/

Real-world Clinical Effectiveness and Safety of ... Vedolizumab showed greater clinical remission and drug persistence than adalimumab, with similar response and mucosal healing rates in Crohn's ...

6. trialx.com trialx.com/clinical-trials/listings/307760/a-study-to-evaluate-adverse-events-how-the-drug-is-tolerated-and-how-the-drug-moves-through-the-body-of-intravenous-infusions-of-abbv-8736-in-adult-healthy-volunteers/

A Study to Evaluate Adverse Events, How the Drug is ... A Study to Evaluate Adverse Events, How the Drug is Tolerated, and How the Drug Moves Through the Body of Intravenous Infusions of ABBV-8736 in ...

7. delta.larvol.com delta.larvol.com/products/?ProductId=82c69728-c61f-410b-92a5-1e598e1fcacc&Index=0

ABBV-8736 / AbbVie ... ABBV-8736 in Adult Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 ... safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers.