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
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