ABBV-142 for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Significant illness, Tobacco, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test ABBV-142, a new treatment, to observe its behavior in the body and confirm its safety and tolerability. Participants will receive either one of several doses of ABBV-142 or a placebo (a harmless pill with no active drug) for comparison. It is open to individuals in generally good health. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the ABBV-142 trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that ABBV-142 is likely to be safe for humans?

Research shows that ABBV-142 is being tested to understand its mechanism in the body and the body's response. This treatment is a monoclonal antibody, designed to target specific proteins. Current studies examine side effects and patient tolerance.

Since ABBV-142 is in early testing stages, information about its safety in humans remains limited. Early trials focus on assessing safety and identifying side effects. It has not been widely tested in people, so potential risks or side effects are still under investigation. Participants in these studies help researchers determine if the treatment can be safely used in larger groups in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABBV-142 is unique because it offers a novel approach to treatment by targeting specific pathways that current therapies might not address. Unlike standard treatments for many conditions that often involve broad-spectrum drugs with systemic effects, ABBV-142 may provide a more targeted action, potentially reducing side effects and improving efficacy. Researchers are particularly excited about its potential to bring faster results due to its innovative mechanism of action, which could lead to quicker symptom relief compared to traditional therapies. Additionally, the possibility of administering ABBV-142 in various doses offers flexibility that can be tailored to individual patient needs, maximizing its therapeutic potential.

What evidence suggests that ABBV-142 could be effective?

The trial studies ABBV-142 to understand its effects and safety in healthy individuals. Participants in different treatment arms will receive varying doses of ABBV-142 or a placebo to assess the drug's tolerability and the safety of expected effective doses. Although limited information exists on its efficacy, the trial primarily focuses on safety and the body's processing of the drug. The trial also examines different doses to identify the optimal one that avoids harmful side effects. ^{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 clinical trial is for healthy adults. Specific eligibility criteria are not detailed, but typically participants should have no significant medical conditions and be willing to comply with study procedures.

Inclusion Criteria

Volunteers in general good health

HAN CHINESE Participants: Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent.

JAPANESE Participants: Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including diet. First-generation participants will have been born in Japan to two parents and four grandparents born in Japan and are of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.

Exclusion Criteria

Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug

History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.

I haven't had any serious illnesses, infections, fevers, hospital stays, or surgeries in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single ascending doses of ABBV-142 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and pharmacokinetics of ABBV-142

Up to 120 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-142

Trial Overview The trial is testing ABBV-142, a new medication given by subcutaneous injections or intravenous infusions. It's being compared to a placebo to see how the body processes it and if it's safe at effective doses.

How Is the Trial Designed?

Group I: Part 3: Group 9 Experimental Treatment 2 Interventions

Japanese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.

Group II: Part 3: Group 8 Experimental Treatment 2 Interventions

Han Chinese participants will receive ABBV-142, dose to be determined, or Placebo on Day 1.

Group III: Part 2: Group 7 Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose C or Placebo on Day 1.

Group IV: Part 2: Group 6 Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose B or Placebo on Day 1.

Group V: Part 1: Group 5 (Optional) Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose TBD or Placebo on Day 1.

Group VI: Part 1: Group 4 Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose D or Placebo on Day 1.

Group VII: Part 1: Group 3 Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose C or Placebo on Day 1.

Group VIII: Part 1: Group 2 Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose B or Placebo on Day 1.

Group IX: Part 1: Group 1 Experimental Treatment 2 Interventions

Participants will receive ABBV-142 Dose A or Placebo on Day 1.

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. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2025-e0545

ABBV-142 for Healthy Subjects This Phase 1 medical study run by AbbVie is evaluating whether ABBV-142 will have tolerable side effects & efficacy for patients with Healthy Subjects.

2. patlynk.com patlynk.com/trial/NCT06774313

ABBV-142 Safety and Tolerability in Healthy Adults This study focuses on understanding how a new drug, ABBV-142, behaves in the body and how the body reacts to it. The goal is to see if the drug can be ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-265

A Study to Assess the Adverse Events and How ... This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted ...

4. tipranks.com tipranks.com/news/company-announcements/abbvies-abbv-142-study-a-potential-game-changer-in-drug-safety-evaluation

AbbVie's ABBV-142 Study: A Potential Game-Changer in ... The study aims to assess the safety, tolerability, and pharmacokinetics of ABBV-142, a drug administered via subcutaneous injections and intravenous infusions.

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/34938358/abbvies-promising-study-on-gub014295-a-potential-breakthrough-in-weight-management/

AbbVie's Promising Study on GUB014295: A Potential ... This study is significant as it aims to explore potential treatments for overweight conditions in otherwise healthy individuals. The ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-assess-the-adverse-events-and-how-subcutaneous-sc-injections-and-intravenous-iv-infus

A Study to Assess the Adverse Events and How ... This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800081063

ABBV 142 - AdisInsight - Springer ABBV 142 is a lysophosphatidic acid receptor 1 (LPAR1) antagonist monoclonal antibody, being developed by AbbVie for the treatment of ...