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Not yet recruitingNCT07856706Updated Oct 5, 2026

A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults

A Phase 1 interventional study of ABBV-7828 and Placebo for ABBV-7828 in Healthy Subjects, sponsored by AbbVie. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Updated Oct 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.

02

Conditions studied

  • Healthy Subjects

Keywords

  • Healthy Adult Subjects
  • ABBV-7828
03

In context

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Part 1: ABBV-7828

    Participants will receive single doses of ABBV-7828.

    Drug: ABBV-7828

  • Placebo comparator
    Part 1: Placebo

    Participants will receive single doses of placebo.

    Drug: Placebo for ABBV-7828

  • Experimental
    Part 2: ABBV-7828 Sequence 1

    Participants will receive ABBV-7828 while in fasting in Period 1 followed by ABBV-7828 after high fat/high calorie meal in Period 2.

    Drug: ABBV-7828

  • Experimental
    Part 2: ABBV-7828 Sequence 2

    Participants will receive ABBV-7828 after a high-fat/high calorie meal in Period 1 followed by ABBV-7828 in fasting conditions in Period 2.

    Drug: ABBV-7828

Interventions

  • DrugABBV-7828

    Oral administration

  • DrugPlacebo for ABBV-7828

    Oral administration

06

What researchers measure

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

    Time frame: Up to approximately 38 days

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-7828

    Cmax of ABBV-7828

    Time frame: Up to approximately 10 days

  3. Time to Cmax (Tmax) of ABBV-7828

    Time to Cmax (Tmax) of ABBV-7828

    Time frame: Up to approximately 10 days

  4. Terminal Phase Elimination Rate Constant (Beta) of ABBV-7828

    Beta of ABBV-7828

    Time frame: Up to approximately 10 days

  5. Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-7878

    AUCt of ABBV-7878

    Time frame: Up to approximately 10 days

  6. AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-7878

    AUCinf of ABBV-7878

    Time frame: Up to approximately 10 days

07

Study locations

1 site
  • Acpru /Id# 283545
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07856706
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Oct 5, 2026
Start date
Sep 21, 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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