Healthy VolunteerPhase 1NCT07222709
A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants
A Phase 1 study testing ABBV-1042 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial summary
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-1042
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 18 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight ˃ 45 kg at the time of screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
Who cannot join
- History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-1042, Placebo
- Keywords
- Healthy Volunteer, ABBV-1042
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1042Drug
Oral Solution
PlaceboDrug
Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| ABBV-1042 or Placebo-Group 1 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. Receives: Drug: ABBV-1042; Drug: Placebo |
| ABBV-1042 or Placebo-Group 2 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. Receives: Drug: ABBV-1042; Drug: Placebo |
| ABBV-1042 or Placebo-Group 3 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. Receives: Drug: ABBV-1042; Drug: Placebo |
| ABBV-1042 or Placebo-Group 4 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. Receives: Drug: ABBV-1042; Drug: Placebo |
| ABBV-1042 or Placebo-Group 5 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. Receives: Drug: ABBV-1042; Drug: Placebo |
| ABBV-1042 or Placebo-Group 6 | Experimental | Participants will receive an oral dose of ABBV-1042 or placebo on day 1. Receives: Drug: ABBV-1042; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to approximately 32 days
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to approximately 3 days
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Measured: Up to approximately 3 days
Number of Participants with Abnormal Change in Physical Examinations
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, and neurological systems will be assessed.
Measured: Up to approximately 3 days
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Measured: Up to approximately 3 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Measured: Up to approximately 3 days
Maximum Plasma Concentration (Cmax) of ABBV-1042
Cmax of ABBV-1042
Measured: Up to approximately 3 days
Time to Cmax (Tmax) of ABBV-1042
Tmax of ABBV-1042
Measured: Up to approximately 3 days
Apparent terminal phase elimination constant (β) of ABBV-1042
β of ABBV-1042
Measured: Up to approximately 3 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042
t1/2 of ABBV-1042
Measured: Up to approximately 3 days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042
AUCt of ABBV-1042
Measured: Up to approximately 3 days
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042
AUCinf of ABBV-1042
Measured: Up to approximately 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start27 Oct 2025
- Primary completion18 Sep 2026
- Study completion18 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
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
- NCT07222709
- Sponsor's protocol ID
- M25-818
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07222709
- Acronym / sponsor ID
- M25-818
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-1042
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 18 Sep 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 30 Oct 2025 (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 will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ABBV-1042 or Placebo-Group 1 | Experimental | Drug: ABBV-1042, Drug: PlaceboParticipants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 2 | Experimental | Drug: ABBV-1042, Drug: PlaceboParticipants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 3 | Experimental | Drug: ABBV-1042, Drug: PlaceboParticipants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 4 | Experimental | Drug: ABBV-1042, Drug: PlaceboParticipants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 5 | Experimental | Drug: ABBV-1042, Drug: PlaceboParticipants will receive an oral dose of ABBV-1042 or placebo on day 1. |
| ABBV-1042 or Placebo-Group 6 | Experimental | Drug: ABBV-1042, Drug: PlaceboParticipants will receive an oral dose of ABBV-1042 or placebo on day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight ˃ 45 kg at the time of screening and upon initial confinement.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG
Key exclusion criteria (2 listed)
- History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.
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-1042Oral Solution | Drug | ABBV-1042 or Placebo-Group 1, ABBV-1042 or Placebo-Group 2, ABBV-1042 or Placebo-Group 3, ABBV-1042 or Placebo-Group 4, ABBV-1042 or Placebo-Group 5, ABBV-1042 or Placebo-Group 6 |
| PlaceboOral Solution | Drug | ABBV-1042 or Placebo-Group 1, ABBV-1042 or Placebo-Group 2, ABBV-1042 or Placebo-Group 3, ABBV-1042 or Placebo-Group 4, ABBV-1042 or Placebo-Group 5, ABBV-1042 or Placebo-Group 6 |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 32 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Time frame: Up to approximately 3 days
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately 3 days
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Number of Participants with Abnormal Change in Physical Examinations
Time frame: Up to approximately 3 days
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, and neurological systems will be assessed.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Time frame: Up to approximately 3 days
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to approximately 3 days
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Maximum Plasma Concentration (Cmax) of ABBV-1042
Time frame: Up to approximately 3 days
Cmax of ABBV-1042
Time to Cmax (Tmax) of ABBV-1042
Time frame: Up to approximately 3 days
Tmax of ABBV-1042
Apparent terminal phase elimination constant (β) of ABBV-1042
Time frame: Up to approximately 3 days
β of ABBV-1042
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042
Time frame: Up to approximately 3 days
t1/2 of ABBV-1042
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042
Time frame: Up to approximately 3 days
AUCt of ABBV-1042
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042
Time frame: Up to approximately 3 days
AUCinf of ABBV-1042
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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. This study is not recruiting at the moment.
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-1042 in people with Healthy Volunteer, 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 2 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: finished, as of the sponsor's last update on 15 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (time frame: Up to approximately 32 days). The study lists 12 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 15 Oct 2026.