ABBV-243 for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiovascular, Respiratory, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effects of a new drug, ABBV-243, in healthy adults. Participants will receive either an intravenous (IV) or subcutaneous (SC) dose of the drug or a placebo to observe the body's reaction. Ideal candidates are in good health without ongoing medical issues, except for mild childhood asthma. Interested individuals should be prepared for regular check-ups and assessments throughout the study. 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 drug.

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

The trial information does not specify whether 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-243 is likely to be safe for humans?

Research shows that ABBV-243, administered either by drip (IV) or injection under the skin (SC), is being tested for safety in people. Studies on similar treatments suggest that single doses of drugs like ABBV-243 are usually well-tolerated, meaning they don't cause unexpected problems. For example, research on similar medications has not found new safety concerns with single doses. However, since this is a Phase 1 trial, the main goal is to check for safety and any side effects.

Participants in these trials often undergo regular check-ups, blood tests, and medical exams to monitor for any possible side effects or unexpected reactions. While specific safety information for ABBV-243 might not be available yet, the trial's careful monitoring is designed to keep participants safe.

Prospective participants should expect regular visits to the hospital or clinic to assess how their bodies respond to the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABBV-243 is unique because it is being tested with both intravenous (IV) and subcutaneous (SC) delivery methods, which could offer flexibility in how the treatment is administered. Unlike traditional treatments that might have a single delivery method, the option for SC administration could enhance convenience and accessibility for patients. Additionally, ABBV-243 might have a new mechanism of action or active ingredient that sets it apart from existing therapies, potentially offering a novel approach to treatment. Researchers are excited about these potential advantages and the possibilities they bring for improving patient outcomes.

What evidence suggests that ABBV-243 could be effective?

Research on ABBV-243 focuses on understanding its mechanism in the body and ensuring its safety. As a new treatment tested in healthy adults, information on its efficacy remains limited. The trial aims to learn how the drug is absorbed and processed and to identify any side effects. Researchers will assess how different doses are tolerated, with participants receiving either ABBV-243 or a placebo. Although specific results on its effectiveness are not yet available, the study seeks to gather crucial information for future research. ^{2 5 6 7 8}

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, including a specific part dedicated to healthy Asian adult volunteers. Participants will undergo frequent medical assessments and tests at a hospital or clinic.

Inclusion Criteria

BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters

I am a woman who cannot become pregnant due to specific medical reasons.

I am a healthy Japanese or Han Chinese person, aged 18-60.

Exclusion Criteria

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

I do not have any uncontrolled serious health conditions.

I have had abnormal cell growth or a history of cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a single intravenous (IV) or subcutaneous (SC) dose of ABBV-243 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, pharmacokinetics, and immunogenicity, including medical assessments, blood tests, and questionnaires

Up to 204 days

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-243

Trial Overview

The study is testing ABBV-243, given either as single ascending IV doses or SC doses in Part 1, and as a single IV dose in Part 2 to evaluate safety, tolerability, how the body processes it (pharmacokinetics), and immune response (immunogenicity).

How Is the Trial Designed?

Group I: Group 8: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Group II: Group 7: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Group III: Group 6: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1

Group IV: Group 5: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1

Group V: Group 4: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1

Group VI: Group 3: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1

Group VII: Group 2: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1

Group VIII: Group 1: ABBV-243 or Placebo Experimental Treatment 2 Interventions

Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, 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

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AbbVie to Feature New Data at ASH 2025 Showcasing ...

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