ABBV-141 for Healthy Adults

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiac, Respiratory, Renal, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effects of a new treatment called ABBV-141 in healthy adults. Researchers aim to determine how the body processes this treatment and identify any side effects. Participants are divided into groups: some will receive ABBV-141 via injection, while others will receive a placebo for comparison. This trial suits healthy adults without major health issues, significant allergies, or medication sensitivities. Participants should also maintain a healthy weight range and, for part of the trial, be of Asian descent. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

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 or your doctor.

Is there any evidence suggesting that ABBV-141 is likely to be safe for humans?

Research shows that ABBV-141 is being studied to determine its safety for healthy adults. Since this treatment is in the early stages of research, limited information about its safety is available. At this stage, researchers focus on understanding how safe this drug is for people.

In the trial, participants receive single doses of ABBV-141 to observe their body's response. This process helps identify any possible side effects early on. Although specific results from past studies on ABBV-141 are not available, early trials typically involve close monitoring to address any negative reactions quickly. This careful observation ensures that only well-tolerated treatments progress to later research stages.

In summary, while detailed safety data for ABBV-141 is not yet available, the trial phase emphasizes safety. Participants can expect thorough monitoring for any side effects, which is standard in early drug development. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABBV-141 because it offers a potentially new way to treat conditions that may currently rely on standard options like monoclonal antibodies targeting specific proteins. Unlike existing treatments, ABBV-141 is an innovative biologic that could introduce a different mechanism of action, potentially targeting novel pathways involved in disease processes. Additionally, ABBV-141 is studied in both intravenous (IV) and subcutaneous (SC) forms, potentially offering more flexibility in how patients receive their treatment, which could enhance convenience and adherence. These features make ABBV-141 a promising candidate for addressing unmet medical needs and improving patient outcomes.

What evidence suggests that ABBV-141 could be effective?

Research on ABBV-141, which participants in this trial may receive, mainly focuses on understanding its safety and mechanism in the body. Since ABBV-141 remains under study, little information exists on its effectiveness for any specific condition. The studies aim to determine how the drug is processed by the body and whether it causes any immune reactions. This step is crucial to ensure the treatment's safety before further testing for effectiveness against specific diseases. Although the exact benefits of ABBV-141 remain unclear, these early studies are essential in the drug's development. ^{1 2 3 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 are either Western or of specific Asian descent (Han Chinese or Japanese). Participants must be in good health as determined by medical exams, have a BMI between 18.0 and 32.0, and for Asians, they need to have parents/grandparents of the same descent.

Inclusion Criteria

My Body Mass Index (BMI) is between 18.0 and 32.0.

You are the first generation with both parents of Han Chinese descent.

You are of Japanese descent with all your parents and grandparents born in Japan.

Exclusion Criteria

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

I have a history of easy bruising, bleeding disorders, or issues with blood clotting.

I have thick, raised scars.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of ABBV-141 or placebo via IV or SC administration

1 day

1 visit (in-person)

Follow-up

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

Up to 85 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-141

Trial Overview The study is testing ABBV-141, a new drug. It's given in different amounts to see how it's tolerated and how it moves through the body compared to a placebo (a substance with no active drug).

How Is the Trial Designed?

Group I: Part 2, ABBV-141 (SC) Experimental Treatment 1 Intervention

Asian participants will receive a single SC dose of ABBV-141.

Group II: Part 2, ABBV-141 (IV) Experimental Treatment 1 Intervention

Asian participants will receive a single IV dose of ABBV-141.

Group III: Part 1, ABBV-141 (subcutaneous [SC]) Experimental Treatment 1 Intervention

Western participants will receive a single SC dose of ABBV-141.

Group IV: Part 1, ABBV-141 (Intravenous [IV]) Experimental Treatment 1 Intervention

Western participants will receive a single IV dose of ABBV-141.

Group V: Part 2, Placebo for ABBV-141 (SC) Placebo Group 1 Intervention

Asian participants will receive a single SC dose of placebo for ABBV-141.

Group VI: Part 1, Placebo for ABBV-141 (IV) Placebo Group 1 Intervention

Western participants will receive a single IV dose of placebo for ABBV-141.

Group VII: Part 1, Placebo for ABBV-141 (SC) Placebo Group 1 Intervention

Western participants will receive a single SC dose of placebo for ABBV-141.

Group VIII: Part 2, Placebo for ABBV-141 (IV) Placebo Group 1 Intervention

Asian participants will receive a single IV dose of placebo for ABBV-141.

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/NCT06148181

NCT06148181 | A Study to Evaluate Adverse Events and ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-693

A Study to Evaluate Adverse Events and How Single ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-adverse-events-and-how-single-ascending-doses-of-abbv-141-move-through-the-body

A Study to Evaluate Adverse Events and How Single ... A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian ...

4. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2024-c4e0b

ABBV-141 for Healthy Adults · Info for Participants The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162360/

Real-World Outcomes of Patients Starting Intravenous and ... Initiating IV VDZ and switching to SC treatment was associated with high persistence rates and improvements in measures of QoL and FCP.

6. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.6103

Safety, Tolerability, and Pharmacokinetics of Single Doses of ... Exidavnemab was found to have an excellent pharmacokinetic profile and was well tolerated in HVs, supporting the continued clinical development.

7. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.6103

Safety, Tolerability, and Pharmacokinetics of Here we present the results from two Phase 1 single dose studies (Study M19-034 and Study M19-465) con- ducted to investigate safety, tolerability, pharmacoki-.