Healthy VolunteersPhase 1NCT07832708
Study to Assess Adverse Events and How Oral ABBV-1162 Moves Through the Body of Healthy Adults
A Phase 1 study testing ABBV-1162 in people with Healthy Volunteers, run by AbbVie.
Trial summary
The goal of this study is to evaluate the safety, tolerability, and pharmacokinetics of ABBV-1162 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-1162
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals in general good health.
- Blood pressure and heart rate measurements within specified ranges: systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, heart rate <= 100 bpm and >= 55 bpm, absence of orthostatic hypotension.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 ofABBV-1162 in Healthy Subjects
The goal of this study is to evaluate the safety, tolerability, and pharmacokinetics of ABBV-1162 in healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-1162, Placebo
- Keywords
- Healthy Volunteers, ABBV-1162
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1162Drug
Oral
PlaceboDrug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ABBV-1162 | Experimental | Participants will receive a single oral dose of ABBV-1162. Receives: Drug: ABBV-1162 |
| Placebo | Placebo comparator | Participants will receive a single oral dose of placebo. Receives: 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 31 days
Maximum Plasma Concentration (Cmax) of ABBV-1162
Cmax of ABBV-1162
Measured: Up to approximately 3 days
Time to Cmax (Tmax) of ABBV-1162
Time to Cmax (Tmax) of ABBV-1162
Measured: Up to approximately 3 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1162
Beta of ABBV-1162
Measured: Up to approximately 3 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1162
t1/2 of ABBV-1162
Measured: Up to approximately 3 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-1162
AUCt of ABBV-1162
Measured: Up to approximately 3 days
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-1162
AUCinf of ABBV-1162
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 posted22 Sep 2026
- Study start2 Nov 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 VolunteersStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT07832708
- Sponsor's protocol ID
- M26-187
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 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 22 Sep 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 ofABBV-1162 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07832708
- Acronym / sponsor ID
- M26-187
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, ABBV-1162
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Sep 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.
The goal of this study is to evaluate the safety, tolerability, and pharmacokinetics of ABBV-1162 in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABBV-1162 | Experimental | Drug: ABBV-1162Participants will receive a single oral dose of ABBV-1162. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single oral dose of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals in general good health.
- Blood pressure and heart rate measurements within specified ranges: systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, heart rate <= 100 bpm and >= 55 bpm, absence of orthostatic hypotension.
Key exclusion criteria (0 listed)
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-1162Oral | Drug | ABBV-1162 |
| PlaceboOral | Drug | Placebo |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 31 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.
Maximum Plasma Concentration (Cmax) of ABBV-1162
Time frame: Up to approximately 3 days
Cmax of ABBV-1162
Time to Cmax (Tmax) of ABBV-1162
Time frame: Up to approximately 3 days
Time to Cmax (Tmax) of ABBV-1162
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1162
Time frame: Up to approximately 3 days
Beta of ABBV-1162
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1162
Time frame: Up to approximately 3 days
t1/2 of ABBV-1162
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-1162
Time frame: Up to approximately 3 days
AUCt of ABBV-1162
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-1162
Time frame: Up to approximately 3 days
AUCinf of ABBV-1162
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 22 Sep 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.
ABBVIE INC. study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-1162 in people with Healthy Volunteers, run by AbbVie.
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 2 inclusion and 0 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Experiencing Adverse Events (time frame: Up to approximately 31 days). The study lists 7 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 22 Sep 2026.