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Monoclonal Antibodies

ABBV-1088 for Healthy Subjects

Phase 1
Recruiting
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 cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia
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 day 32

Summary

This trial will test the safety, tolerance, and how the body processes a single dose of ABBV-1088 in healthy adults.

Who is the study for?
This trial is for healthy adults who can safely participate in a study to test the effects of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.
What is being tested?
The trial is testing ABBV-1088, a new drug. Participants will receive either ABBV-1088 or a placebo (a substance with no therapeutic effect) to compare safety, tolerability, and how the body processes the drug.
What are the potential side effects?
Since this is an early-stage trial for ABBV-1088 in healthy individuals, potential side effects are being investigated; however, common side effects may include nausea, headache, dizziness or allergic reactions.

Eligibility Criteria

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 32
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 32 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088
Maximum Plasma Concentration (Cmax) of ABBV-1088
+4 more

Trial Design

12Treatment groups
Experimental Treatment
Group I: Group 6- PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo day 1
Group II: Group 6- ABBV-1088 Dose FExperimental Treatment1 Intervention
Participants will receive single dose of ABBV-1088 dose F on day 1
Group III: Group 5- PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo day 1
Group IV: Group 5- ABBV-1088 Dose EExperimental Treatment1 Intervention
Participants will receive single dose of ABBV-1088 dose E on day 1
Group V: Group 4- PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo day 1
Group VI: Group 4- ABBV-1088 Dose DExperimental Treatment1 Intervention
Participants will receive single dose of ABBV-1088 dose D on day 1
Group VII: Group 3- PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo day 1
Group VIII: Group 3- ABBV-1088 Dose CExperimental Treatment1 Intervention
Participants will receive single dose of ABBV-1088 dose C on day 1
Group IX: Group 2- PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo day 1
Group X: Group 2- ABBV-1088 Dose BExperimental Treatment1 Intervention
Participants will receive single dose of ABBV-1088 dose B on day 1
Group XI: Group 1- PlaceboExperimental Treatment1 Intervention
Participants will receive single dose of placebo day 1
Group XII: Group 1- ABBV-1088 Dose AExperimental Treatment1 Intervention
Participants will receive single dose of ABBV-1088 dose A on day 1

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor
1,022 Previous Clinical Trials
520,131 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
443 Previous Clinical Trials
160,617 Total Patients Enrolled
~0 spots leftby Nov 2024
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