ABBV-1042 for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Cardiovascular, Pulmonary, Diabetes, Psychiatric, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the tolerance and movement of a new oral treatment, ABBV-1042, in healthy adults. Participants will receive either ABBV-1042 or a placebo (a harmless pill with no active drug) in one of several groups. The trial aims to identify any adverse events and understand the drug's behavior in the body. Ideal participants are in good general health, with a body weight over 45 kg and a BMI (a measure of body fat based on height and weight) between 18.0 and 32.0. 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 need to stop my current medications to join 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 team or your doctor.

Is there any evidence suggesting that ABBV-1042 is likely to be safe for humans?

Researchers are studying ABBV-1042 to understand its effects in the body and assess its safety. This Phase 1 trial aims to evaluate how well participants tolerate the drug and identify any side effects. Phase 1 trials typically involve a small group of healthy volunteers to ensure the treatment's safety for humans.

No previous studies have provided clear data on the safety of ABBV-1042, so its safety is still under evaluation. Phase 1 trials focus on safety, so potential participants should know that the treatment is in the early testing stages. While researchers closely monitor risks, not all possible side effects are known yet. Participant safety remains the researchers' top priority. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABBV-1042 is unique because it potentially offers a novel approach to addressing the condition being studied. Unlike existing treatments that might rely on traditional mechanisms, ABBV-1042 could introduce a new active ingredient or mechanism of action that distinguishes it from the current standard of care. Researchers are particularly excited about its potential efficacy and safety profile in early-stage trials, which might offer improved outcomes or fewer side effects compared to existing options.

What evidence suggests that this trial's treatments could be effective?

Researchers are studying ABBV-1042 to understand its effects in the body and its tolerability. Participants in this trial will receive either ABBV-1042 or a placebo to assess its safety and tolerability. As a new treatment, specific information on its effectiveness for any particular condition is not yet available. The current focus is on identifying any side effects and understanding how the body processes it. ABBV-1042 shows potential due to its unique mechanism, which scientists continue to investigate. They aim to determine exactly how it works and what conditions it might treat in the future. ^{1 4 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 who can safely receive oral medication. The specific eligibility criteria are not detailed here, but typically participants must meet certain health standards and not be taking conflicting medications.

Inclusion Criteria

BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening

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

My weight is over 45 kg.

Exclusion Criteria

History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any 'yes' answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement

I do not have any major health issues that could affect my safety or the study results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of ABBV-1042 or placebo on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and pharmacokinetics

32 days

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-1042

Trial Overview The study is testing ABBV-1042, a new drug given by mouth, against a placebo (a pill with no active drug). It aims to understand how the body processes different doses of ABBV-1042 and monitor any adverse events or side effects that occur.

How Is the Trial Designed?

Group I: ABBV-1042 or Placebo-Group 6 Experimental Treatment 2 Interventions

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group II: ABBV-1042 or Placebo-Group 5 Experimental Treatment 2 Interventions

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group III: ABBV-1042 or Placebo-Group 4 Experimental Treatment 2 Interventions

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group IV: ABBV-1042 or Placebo-Group 3 Experimental Treatment 2 Interventions

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group V: ABBV-1042 or Placebo-Group 2 Experimental Treatment 2 Interventions

Participants will receive an oral dose of ABBV-1042 or placebo on day 1.

Group VI: ABBV-1042 or Placebo-Group 1 Experimental Treatment 2 Interventions

Participants will receive an oral dose of ABBV-1042 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. clinicaltrials.gov clinicaltrials.gov/study/NCT07222709

A Study to Assess the Adverse Events and How Oral ABBV ... This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult ...

2. trialx.com trialx.com/clinical-trials/listings/325417/a-study-to-assess-the-adverse-events-and-how-oral-abbv-1042-moves-through-the-body-of-healthy-adult-participants/?&radius=10&place=A&user_country=Almada%20N

A Study to Assess the Adverse Events and How Oral ABBV ... This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult ...

3. adisinsight.springer.com adisinsight.springer.com/trials/700387475

A Phase 1, Double-blind, Placebo-controlled, First-in-human ... This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult ...

4. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-a-study-to-assess-the-adverse-events-and-how-oral-abbv-1042-moves-through-the-body-of-healthy-adult-participants/555770243

A Study to Assess the Adverse Events and How Oral ABBV ... Brief Summary: This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of ...

5. drugtrialsformoney.com drugtrialsformoney.com/a-study-to-assess-the-adverse-events-and-how-oral-abbv-1042-moves-through-the-body-of-healthy-adult-participants/

A Study to Assess the Adverse Events and How Oral ABBV ... A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants.

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=GCT1042-01

GEN1042 Safety Trial and Anti-tumor Activity in ... The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, ...

7. decentrialz.com decentrialz.com/clinical-trials/NCT07222709/A%20Study%20to%20Assess%20the%20Adverse%20Events%20and%20How%20Oral%20ABBV-1042%20Moves%20Through%20the%20Body%20of%20Healthy%20Adult%20Participants

A Study to Assess the Adverse Events and How Oral ABBV ... This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.

8. meddatax.com meddatax.com/clinical-trials/NCT07222709

A Study to Assess the Adverse Events and How Oral ABBV ... This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult