Healthy SubjectsPhase 1NCT07856706
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
A Phase 1 study testing ABBV-7828 in people with Healthy Subjects, run by AbbVie at 1 site in United States.
Trial summary
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ABBV-7828
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
- Conditions
- Healthy Subjects
- Being tested
- ABBV-7828, Placebo for ABBV-7828
- Keywords
- Healthy Adult Subjects, ABBV-7828
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-7828Drug
Oral administration
Placebo for ABBV-7828Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1: ABBV-7828 | Experimental | Participants will receive single doses of ABBV-7828. Receives: Drug: ABBV-7828 |
| Part 1: Placebo | Placebo comparator | Participants will receive single doses of placebo. Receives: Drug: Placebo for ABBV-7828 |
| Part 2: ABBV-7828 Sequence 1 | Experimental | Participants will receive ABBV-7828 while in fasting in Period 1 followed by ABBV-7828 after high fat/high calorie meal in Period 2. Receives: Drug: ABBV-7828 |
| Part 2: ABBV-7828 Sequence 2 | Experimental | 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. Receives: Drug: ABBV-7828 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 38 days
Maximum Observed Serum Concentration (Cmax) of ABBV-7828
Cmax of ABBV-7828
Measured: Up to approximately 10 days
Time to Cmax (Tmax) of ABBV-7828
Time to Cmax (Tmax) of ABBV-7828
Measured: Up to approximately 10 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-7828
Beta of ABBV-7828
Measured: Up to approximately 10 days
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
Measured: Up to approximately 10 days
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-7878
AUCinf of ABBV-7878
Measured: Up to approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start21 Sep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856706
- Sponsor's protocol ID
- M25-756
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07856706
- Acronym / sponsor ID
- M25-756
- Conditions
- Healthy Subjects
- Keywords
- Healthy Adult Subjects, ABBV-7828
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate safety, tolerability, pharmacokinetics and effect of food on ABBV-7828 compared to placebo in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: ABBV-7828 | Experimental | Drug: ABBV-7828Participants will receive single doses of ABBV-7828. |
| Part 1: Placebo | Placebo comparator | Drug: Placebo for ABBV-7828Participants will receive single doses of placebo. |
| Part 2: ABBV-7828 Sequence 1 | Experimental | Drug: ABBV-7828Participants will receive ABBV-7828 while in fasting in Period 1 followed by ABBV-7828 after high fat/high calorie meal in Period 2. |
| Part 2: ABBV-7828 Sequence 2 | Experimental | Drug: ABBV-7828Participants will receive ABBV-7828 after a high-fat/high calorie meal in Period 1 followed by ABBV-7828 in fasting conditions in Period 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-7828Oral administration | Drug | Part 1: ABBV-7828, Part 2: ABBV-7828 Sequence 1, Part 2: ABBV-7828 Sequence 2 |
| Placebo for ABBV-7828Oral administration | Drug | Part 1: Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 38 days
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.
Maximum Observed Serum Concentration (Cmax) of ABBV-7828
Time frame: Up to approximately 10 days
Cmax of ABBV-7828
Time to Cmax (Tmax) of ABBV-7828
Time frame: Up to approximately 10 days
Time to Cmax (Tmax) of ABBV-7828
Terminal Phase Elimination Rate Constant (Beta) of ABBV-7828
Time frame: Up to approximately 10 days
Beta of ABBV-7828
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-7878
Time frame: Up to approximately 10 days
AUCt of ABBV-7878
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-7878
Time frame: Up to approximately 10 days
AUCinf of ABBV-7878
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-7828 in people with Healthy Subjects, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to approximately 38 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.