ABBV-1088 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Neurological, Respiratory, Endocrine, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the safety and tolerability of the new drug ABBV-1088, both alone and with itraconazole. Different groups receive either ABBV-1088 or a placebo (an inactive substitute) for varying periods to assess how the body processes the drug. Healthy adults from Western, Han-Chinese, and Japanese backgrounds can participate if they are in good health and have a BMI (a measure of body fat) between 18 and 32. This study primarily targets individuals without significant medical conditions affecting daily life. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants and assesses drug interactions, it's possible that you may need to pause some medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that ABBV-1088 is likely to be safe for humans?

Research has shown that ABBV-1088 is being tested for safety in healthy adults. As this trial is in the early stages, researchers continue to gather evidence on its safety. Early trials typically begin with low doses to monitor for any side effects.

Previous studies have not reported serious safety problems with ABBV-1088, but it is important to note that trials are still ongoing. Participants might experience mild side effects, such as headaches or nausea, which are common in early tests, while serious issues remain rare at this stage.

Overall, ABBV-1088 appears well-tolerated so far, but researchers are still collecting more data to confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

ABBV-1088 is unique because it introduces a potentially novel mechanism of action that sets it apart from standard treatments. Most existing therapies for conditions like inflammation typically target broad immune responses, but ABBV-1088 is designed to hone in on specific pathways, potentially offering more precise intervention. Researchers are excited about ABBV-1088 because this targeted approach might reduce side effects and improve effectiveness, offering a promising advancement in treatment options. Additionally, ABBV-1088 is being tested across diverse population groups and dosing schedules, which could provide valuable insights into its versatility and effectiveness.

What evidence suggests that ABBV-1088 could be effective?

Research on ABBV-1088 remains in the early stages. This trial focuses on understanding how the body processes the drug and ensuring its safety for healthy adults. Participants will receive varying doses of ABBV-1088 or a placebo, with some groups also receiving itraconazole to study drug interactions. Researchers are testing the drug in different groups, including individuals from Western, Han-Chinese, and Japanese backgrounds, to observe its behavior in diverse populations. Although the exact mechanism and potential conditions it may treat are not yet known, ongoing research lays the groundwork for future studies on its potential benefits. ^{1 2 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, including Western, Han-Chinese, and Japanese individuals. Participants must meet certain health standards but specific inclusion criteria are not listed here. People with conditions that could interfere with the study or pose a risk to their safety are likely excluded.

Inclusion Criteria

Body Mass Index (BMI) is greater than or equal to 18.0 and less than or equal to 32.0 kg/m^2 after rounding to the tenths decimal, at Screening and upon confinement

I am generally healthy based on recent medical exams.

Part 3 Only: Han Chinese Participant must be first- or second-generation Han Chinese of full Chinese parentage. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR Japanese Participant must be first- or second-generation Japanese of full Japanese parentage. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

Exclusion Criteria

History of suicidal ideation within one year prior to study drug administration as evidenced by answering 'yes' to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.

I do not have any major health issues apart from my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various doses of ABBV-1088 or placebo for up to 21 days

21 days

Drug-Drug Interaction Study

Participants receive ABBV-1088 with itraconazole to assess drug-drug interaction

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-1088

Trial Overview

The study is testing ABBV-1088's effects in multiple doses and its interaction with another drug called Itraconazole (ITZ). Some participants will receive a placebo instead of ABBV-1088 to compare results.

How Is the Trial Designed?

Group I: Part 3: Group 2 ABBV-1088 Japanese Participants Experimental Treatment 1 Intervention

Japanese participants will receive ABBV-1088 dose E on day 1

Group II: Part 3: Group 1 ABBV-1088 Han Chinese Participants Experimental Treatment 1 Intervention

Han Chinese participants will receive ABBV-1088 dose E on day 1

Group III: Part 2: Period 2 ABBV-1088 Dose A with ITZ Experimental Treatment 2 Interventions

Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days

Group IV: Part 2: Period 1 ABBV-1088 Dose A Experimental Treatment 1 Intervention

Participants will receive ABBV-1088 Dose A on day 1

Group V: Part 1: Group 5 Placebo Experimental Treatment 1 Intervention

Participants older than 60 years of age will receive placebo for 21 days

Group VI: Part 1: Group 5 ABBV-1088 Dose D Experimental Treatment 1 Intervention

Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days

Group VII: Part 1: Group 4 Placebo Experimental Treatment 1 Intervention

Participants will receive placebo for 21 days

Group VIII: Part 1: Group 4 ABBV-1088 Dose D Experimental Treatment 1 Intervention

Participants will receive ABBV-1088 dose D for 21 days

Group IX: Part 1: Group 3 Placebo Experimental Treatment 1 Intervention

Participants will receive placebo for 7 days

Group X: Part 1: Group 3 ABBV-1088 Dose C Experimental Treatment 1 Intervention

Participants will receive ABBV-1088 dose C for 7 days

Group XI: Part 1: Group 2 Placebo Experimental Treatment 1 Intervention

Participants will receive placebo for 21 days

Group XII: Part 1: Group 2 ABBV-1088 Dose B Experimental Treatment 1 Intervention

Participants will receive ABBV-1088 dose B for 21 days

Group XIII: Part 1: Group 1 Placebo Experimental Treatment 1 Intervention

Participants will receive placebo for 7 days

Group XIV: Part 1: Group 1 ABBV-1088 Dose A Experimental Treatment 1 Intervention

Participants will receive ABBV-1088 dose A for 7 days

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/NCT06579300

NCT06579300 | A Study to Assess Multiple Ascending ...

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants.

2.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=M24-929

A Study to Assess the Safety, Tolerability, and ...

This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants.

3.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-8-2024-584f7

ABBV-1088 for Healthy Subjects · Info for Participants

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants.

4.

trial.medpath.com

trial.medpath.com/clinical-trial/cd0894cb2128d689/nct06414798-safety-tolerability-pharmacokinetics-abbv-1088

A Study to Assess the Safety, Tolerability, and ... - MedPath

This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants.

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06579300/a-study-to-assess-multiple-ascending-dose-drug-drug-interaction-and-asian-pharmacokinetic-study-of-abbv-1088

A Study to Assess Multiple Ascending Dose, Drug- ...

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese ...

6.

trialx.com

trialx.com/clinical-trials/listings/298456/a-study-to-assess-multiple-ascending-dose-drug-drug-interaction-and-asian-pharmacokinetic-study-of-abbv-1088/

A Study to Assess Multiple Ascending Dose, Drug- ...

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese ...

7.

abbvieclinicaltrials.com

abbvieclinicaltrials.com/study/?id=M24-931

A Study to Assess Multiple Ascending Dose, Drug- ...

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants.