ABBV-1088 for Healthy Subjects

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

66 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

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

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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