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ABBV-722 Safety Study in Healthy Adults
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
Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 44
Summary
This trial is the first time ABBV-722 is being tested in humans. It aims to see how safe and well-tolerated the drug is when taken by mouth by healthy adults.
Who is the study for?
This trial is for healthy adults who want to participate in a study testing a new drug. Specific criteria for joining or being excluded aren't provided, but typically participants must meet certain health standards and not be taking conflicting medications.
What is being tested?
The study is looking at how the body processes ABBV-722 when taken orally, what side effects occur, and if it's easy to tolerate. Some people will get the actual drug while others will receive a placebo (a pill without any active drug) to compare results.
What are the potential side effects?
Since this is an early-phase trial for ABBV-722, potential side effects are not fully known yet. However, common reactions may include nausea, headache, dizziness or allergic reactions which are typical observations in such studies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy Han Chinese or Japanese individual aged 18-65.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 44
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 44
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Normalized AUCs
Dose Normalized Cmax
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722
+8 moreTrial Design
11Treatment groups
Experimental Treatment
Group I: Part 3: Group 9Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose C or placebo for 14 days.
Group II: Part 3: Group 8Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose B or placebo for 14 days.
Group III: Part 3: Group 11Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose E or placebo for 14 days.
Group IV: Part 3: Group 10Experimental Treatment2 Interventions
Participants will receive either ABBV-722 Dose D or placebo for 14 days.
Group V: Part 2: Group 7Experimental Treatment1 Intervention
Participants who are Japanese will receive a single dose of ABBV-722 Dose C.
Group VI: Part 2: Group 6Experimental Treatment1 Intervention
Participants who are Han Chinese will receive a single dose of ABBV-722 Dose C.
Group VII: Part 1: Group 5Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose E or placebo.
Group VIII: Part 1: Group 4Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose D or placebo.
Group IX: Part 1: Group 3Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose C or placebo.
Group X: Part 1: Group 2Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose B or placebo.
Group XI: Part 1: Group 1Experimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-722 Dose A or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,491 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,276 Total Patients Enrolled