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ABBV-1088 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 54 days
Awards & highlights

Summary

This trial will test the safety and how well ABBV-1088 is tolerated in healthy adults from different backgrounds. It will also look at how ABBV-1088 interacts with itra

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones may include reactions at the injection site, nausea, headaches, or fatigue. Drug interactions might also affect liver enzymes or cause other unforeseen issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any major health issues apart from my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 54 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 54 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Adverse Events (AEs)
Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
+6 more

Trial Design

14Treatment groups
Experimental Treatment
Group I: Part 3: Group 2 ABBV-1088 Japanese ParticipantsExperimental Treatment1 Intervention
Japanese participants will receive ABBV-1088 dose E on day 1
Group II: Part 3: Group 1 ABBV-1088 Han Chinese ParticipantsExperimental Treatment1 Intervention
Han Chinese participants will receive ABBV-1088 dose E on day 1
Group III: Part 2: Period 2 ABBV-1088 Dose A with ITZExperimental Treatment2 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 AExperimental Treatment1 Intervention
Participants will receive ABBV-1088 Dose A on day 1
Group V: Part 1: Group 5 PlaceboExperimental Treatment1 Intervention
Participants older than 60 years of age will receive placebo for 21 days
Group VI: Part 1: Group 5 ABBV-1088 Dose DExperimental Treatment1 Intervention
Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days
Group VII: Part 1: Group 4 PlaceboExperimental Treatment1 Intervention
Participants will receive placebo for 21 days
Group VIII: Part 1: Group 4 ABBV-1088 Dose DExperimental Treatment1 Intervention
Participants will receive ABBV-1088 dose D for 21 days
Group IX: Part 1: Group 3 PlaceboExperimental Treatment1 Intervention
Participants will receive placebo for 7 days
Group X: Part 1: Group 3 ABBV-1088 Dose CExperimental Treatment1 Intervention
Participants will receive ABBV-1088 dose C for 7 days
Group XI: Part 1: Group 2 PlaceboExperimental Treatment1 Intervention
Participants will receive placebo for 21 days
Group XII: Part 1: Group 2 ABBV-1088 Dose BExperimental Treatment1 Intervention
Participants will receive ABBV-1088 dose B for 21 days
Group XIII: Part 1: Group 1 PlaceboExperimental Treatment1 Intervention
Participants will receive placebo for 7 days
Group XIV: Part 1: Group 1 ABBV-1088 Dose AExperimental Treatment1 Intervention
Participants will receive ABBV-1088 dose A for 7 days

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
1,004 Previous Clinical Trials
513,712 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
430 Previous Clinical Trials
156,032 Total Patients Enrolled
~44 spots leftby Nov 2025
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