Healthy VolunteerPhase 1NCT07024797
Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult Chinese Participants
A Phase 1 study testing ABBV-932 in people with Healthy Volunteer, run by AbbVie at 1 site in China.
Trial summary
This study will assess the adverse events, tolerability, and how oral doses of ABBV-932 moves through the body in healthy adult Chinese 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-932
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2025to 8 Dec 2025
- 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
- Body Mass Index (BMI) ≥ 18.0 to ≤ 27.9 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, unexplained syncope, or any uncontrolled medical illness.
- History of suicidal ideation within one year prior to study treatment administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts as evidenced by answering "yes" to any suicidal behavior question (except a "yes" to the "Has subject engaged in non-suicidal self-injurious behavior" question) within the last 2 years.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center /ID# 273427
Shanghai, Shanghai Municipality, 200030
About this study
Official title: A Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Chinese Subjects
This study will assess the adverse events, tolerability, and how oral doses of ABBV-932 moves through the body in healthy adult Chinese participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-932, Placebo for ABBV-932
- Keywords
- Healthy Volunteer, ABBV-932
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-932Drug
Oral Capsule
Placebo for ABBV-932Drug
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| ABBV-932 or Placebo Part A | Experimental | Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days. Receives: Drug: ABBV-932; Drug: Placebo for ABBV-932 |
| ABBV-932 or Placebo Part B | Experimental | Participants will receive oral ABBV-932 or placebo QD for 14 days. Receives: Drug: ABBV-932; Drug: Placebo for ABBV-932 |
| ABBV-932 or Placebo Part C | Experimental | Participants will receive oral ABBV-932 or placebo QD 42 days. Receives: Drug: ABBV-932; Drug: Placebo for ABBV-932 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of ABBV-932
Cmax of ABBV-932
Measured: Up to approximately 43 days
Time to Cmax (Tmax) of ABBV-932
Tmax of ABBV-932
Measured: Up to approximately 43 days
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932
Ctrough of ABBV-932
Measured: Up to approximately 43 days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932
AUCtau of ABBV-932
Measured: Up to approximately 43 days
Maximum Plasma Concentration (Cmax) of DCAR
Cmax of DCAR
Measured: Up to approximately 43 days
Time to Cmax (Tmax) of DCAR
Tmax of DCAR
Measured: Up to approximately 43 days
Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR
Ctrough of DCAR
Measured: Up to approximately 43 days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)
AUCtau of DCAR
Measured: Up to approximately 43 days
Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)
Cmax of DDCAR
Measured: Up to approximately 43 days
Time to Cmax (Tmax) of DDCAR
Tmax of DDCAR
Measured: Up to approximately 43 days
Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR
Ctrough of DDCAR
Measured: Up to approximately 43 days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR
AUCtau of DDCAR
Measured: Up to approximately 43 days
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 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start21 Aug 2025
- Primary completion8 Dec 2025
- Study completion8 Dec 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT07024797
- Sponsor's protocol ID
- M25-644
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2025
- Last updated
- 31 Dec 2025
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Chinese Subjects
- ClinicalTrials.gov ID
- NCT07024797
- Acronym / sponsor ID
- M25-644
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-932
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 8 Dec 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 17 Jun 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 doses of ABBV-932 moves through the body in healthy adult Chinese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABBV-932 or Placebo Part A | Experimental | Drug: ABBV-932, Drug: Placebo for ABBV-932Participants will receive oral ABBV-932 or placebo once daily (QD) for 14 days. |
| ABBV-932 or Placebo Part B | Experimental | Drug: ABBV-932, Drug: Placebo for ABBV-932Participants will receive oral ABBV-932 or placebo QD for 14 days. |
| ABBV-932 or Placebo Part C | Experimental | Drug: ABBV-932, Drug: Placebo for ABBV-932Participants will receive oral ABBV-932 or placebo QD 42 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) ≥ 18.0 to ≤ 27.9 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- 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 epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, unexplained syncope, or any uncontrolled medical illness.
- History of suicidal ideation within one year prior to study treatment administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts as evidenced by answering "yes" to any suicidal behavior question (except a "yes" to the "Has subject engaged in non-suicidal self-injurious behavior" question) within the last 2 years.
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-932Oral Capsule | Drug | ABBV-932 or Placebo Part A, ABBV-932 or Placebo Part B, ABBV-932 or Placebo Part C |
| Placebo for ABBV-932Oral Capsule | Drug | ABBV-932 or Placebo Part A, ABBV-932 or Placebo Part B, ABBV-932 or Placebo Part C |
Primary outcome
Maximum Plasma Concentration (Cmax) of ABBV-932
Time frame: Up to approximately 43 days
Cmax of ABBV-932
Time to Cmax (Tmax) of ABBV-932
Time frame: Up to approximately 43 days
Tmax of ABBV-932
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-932
Time frame: Up to approximately 43 days
Ctrough of ABBV-932
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine ABBV-932
Time frame: Up to approximately 43 days
AUCtau of ABBV-932
Maximum Plasma Concentration (Cmax) of DCAR
Time frame: Up to approximately 43 days
Cmax of DCAR
Time to Cmax (Tmax) of DCAR
Time frame: Up to approximately 43 days
Tmax of DCAR
Observed plasma concentration at the end of a dosing interval (Ctrough) of DCAR
Time frame: Up to approximately 43 days
Ctrough of DCAR
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of Desmethyl Cariprazine (DCAR)
Time frame: Up to approximately 43 days
AUCtau of DCAR
Maximum Plasma Concentration (Cmax) of Didesmethyl-Cariprazine (DDCAR)
Time frame: Up to approximately 43 days
Cmax of DDCAR
Time to Cmax (Tmax) of DDCAR
Time frame: Up to approximately 43 days
Tmax of DDCAR
Observed plasma concentration at the end of a dosing interval (Ctrough) of DDCAR
Time frame: Up to approximately 43 days
Ctrough of DDCAR
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of DDCAR
Time frame: Up to approximately 43 days
AUCtau of DDCAR
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 75 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.
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 31 Dec 2025.
- 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. 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-932 in people with Healthy Volunteer, run by AbbVie at 1 site in China.
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 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 31 Dec 2025. 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 China. 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?
Maximum Plasma Concentration (Cmax) of ABBV-932 (time frame: Up to approximately 43 days). The study lists 13 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 31 Dec 2025.