ABBV-722 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to examine how the experimental drug ABBV-722 moves through the body under different conditions: on an empty stomach and after a high-fat meal. The study will determine how food affects the drug’s availability in the body. Candidates may be suitable if they are generally healthy and have not experienced any major illness or surgery recently. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Is there any evidence suggesting that ABBV-722 is likely to be safe for humans?
Research has shown that ABBV-722 underwent thorough testing in early studies. Participants generally tolerated the treatment well, with most side effects being mild to moderate. Approximately 80.7% of doses caused mild local symptoms, such as redness or swelling, while 45.5% led to mild general symptoms, like headaches or tiredness. Importantly, no serious side effects were reported, suggesting that ABBV-722 is safe for use in controlled settings.12345
Why are researchers excited about this trial's treatment?
ABBV-722 is unique because it is being tested under different dietary conditions to see how it performs, which isn't common with many treatments. Unlike the standard of care that might not consider the impact of food on drug absorption, ABBV-722 is assessed both in fasted and fed states, potentially offering more flexibility and precision in real-world settings. Researchers are excited about ABBV-722 because understanding its interaction with food could lead to better dosing recommendations and improved patient outcomes, making it a promising new option in treatment strategies.
What evidence suggests that ABBV-722 could be effective?
Research on ABBV-722 is in the early stages, focusing on the drug's movement through the body and its safety. In this trial, participants will receive single doses of ABBV-722 under different conditions: one group will take it while fasting, another with a high-fat meal, and a third will receive a different single dose while fasting. The main goal is to determine how quickly and how much of the drug enters the bloodstream. No information exists yet on its effectiveness for any specific condition. Currently, the focus is on understanding the drug's behavior and safety in healthy individuals.12567
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 who can safely take a new tablet called ABBV-722. Participants should not have any significant health issues that could affect the study or be at risk from taking the tablet.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1: Single Dose A (Fasted)
Single dose of ABBV-722 administered under fasted conditions
Period 2: Single Dose A (Fed)
Single dose of ABBV-722 administered under fed conditions (high-fat meal)
Period 3: Single Dose B (Fasted)
Single dose of ABBV-722 administered under fasted conditions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-722
Trial Overview
The study is testing how the body absorbs ABBV-722 when taken as a tablet without food, and how this changes if you take it with food. It's to see if eating affects the drug's effectiveness.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Single dose will be administered under fasted conditions
Single dose will be administered under fed (high-fat meal) conditions
Single dose will be administered under fasted conditions
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
A Phase 1 Study of a Tablet Form of ABBV-722 Taken With ...
A Phase 1 Study to Evaluate the Pharmacokinetics of a Tablet Formulation of ABBV-722 and the Effect of Food on Its Bioavailability in Healthy Adult Subjects.
NCT06673238 | A Study to Assess How the Drug Moves ...
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
A Study to Assess How the Drug Moves Through the Body ...
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult ...
4.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/37253621/abbvie-advances-early-stage-abbv-722-tablet-study-underscoring-pipeline-momentum/AbbVie Advances Early-Stage ABBV-722 Tablet Study, ...
Healthy adults receive single doses of the drug under different eating conditions. The goal is to understand how quickly and how much of ABBV- ...
A Phase 1 Study to Evaluate the Pharmacokinetics of a Tablet ...
The objective of this study is to evaluate the PK of a tablet formulation of ABBV-722 under fasted conditions and the effect of food on its ...
A First-In-Human Study to Evaluate the Pharmacokinetics ...
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy ...
ABBV-722 Safety Study in Healthy Adults
The vaccine was well-tolerated, with mild to moderate local and general symptoms reported after 80.7% and 45.5% of doses, respectively, and no participants ...
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