ABBV-7828 safety and food effect study in healthy adults
Official title: A Phase 1, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-7828, and to Evaluate the Effect of Food on ABBV-7828 Pharmacokinetics in Healthy Adult Subjects
Run by AbbVie · NCT07856706 · Data updated 2026-11-12
This study tests ABBV-7828 versus placebo in healthy adults to see how safe it is, how it behaves in the body, and how food changes its effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Status | Recruiting |
| Started | October 2, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07856706 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 65 who are generally healthy with BMI between 18.0 and 32.0 kg/m2.
✕Probably not a fit
Participants with certain cardiac issues, significant organ diseases, or uncontrolled medical conditions may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, single ascending dose trial designed to evaluate safety, tolerability, and pharmacokinetics of ABBV-7828, as well as the impact of food on its pharmacokinetics, in healthy adults. Participants will be randomly assigned to receive ABBV-7828 or placebo under fed and fasted conditions to understand dose-related safety signals and how meals influence exposure. The study uses sequential dose groups with close monitoring and standard lab and ECG assessments. Outcomes focus on adverse events, vital signs, laboratory tests, and drug concentration in blood.
Why it matters
Potential benefit: If successful, the study could help determine a safe starting dose and how to take ABBV-7828 with regard to meals.
How similar studies have gone: Phase 1 studies of similar compounds have shownClear safety and pharmacokinetic data in healthy volunteers, supporting progression to later trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals between 18 to 65 years of age at the time of screening. * BMI is \<= 18.0 to \>= 32.0 kg/m2. * A condition of general good health, based upon the results of a medical history, physical evaluations, vital signs, laboratory profile and a 12-lead ECG. Exclusion Criteria: * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * Has any clinically significant ECG abnormalities including the following: * Evidence of 2nd or 3rd degree atrial ventricular (AV) block at screening visit or upon initial confinement * QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) \> 450 msec (males) or \> 460 msec (females) at screening visit or upon initial confinement. * History of any clinically significant sensitivity or allergy to any medication or food. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption.
Where it's running
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Acpru /Id# 283545
Grayslake, Illinois, United States Recruiting
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.