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
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