Healthy VolunteerPhase 1NCT07219030
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
A Phase 1 study testing Emraclidine in people with Healthy Volunteer, run by AbbVie at 5 sites in United States.
Trial summary
This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Emraclidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Oct 2025to Dec 2026
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older 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 any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, genitourinary, immunological, hematologic, neurological or psychiatric disease or disorder, or any other uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Completed
Altasciences Clinical Los Angeles /ID# 276854
Cypress, California, 90630
- Recruiting
Acpru /Id# 276996
Grayslake, Illinois, 60030
Site Coordinator, 847-935-4400
- Recruiting
K2 Medical Research, LLC /ID# 276636
Maitland, Florida, 32751
- Recruiting
Hassman Research Institute Marlton Site /ID# 276876
Marlton, New Jersey, 08053
Site Coordinator, 888-437-4104
- Recruiting
Clinical Pharmacology Of Miami /ID# 276856
Miami, Florida, 33172
Site Coordinator, 786-493-9466
About this study
Official title: A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Emraclidine Following Multiple Ascending Oral Doses in Healthy Elderly Subjects
This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
- Conditions
- Healthy Volunteer
- Being tested
- Emraclidine, Placebo
- Keywords
- Healthy Volunteer, ABBV-1231
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmraclidineDrug
Oral tablets
PlaceboDrug
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Emraclidine or Placebo- Group 1 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days Receives: Drug: Emraclidine; Drug: Placebo |
| Emraclidine or Placebo- Group 2 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days Receives: Drug: Emraclidine; Drug: Placebo |
| Emraclidine or Placebo- Group 3 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. Receives: Drug: Emraclidine; Drug: Placebo |
| Emraclidine or Placebo- Group 4 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. Receives: Drug: Emraclidine; Drug: Placebo |
| Emraclidine or Placebo- Group 5 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. Receives: Drug: Emraclidine; Drug: Placebo |
| Emraclidine or Placebo- Group 6 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. Receives: Drug: Emraclidine; 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 50 days
Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements
Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to approximately 20 days
Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Measured: Up to approximately 20 days
Number of Participants with Clinical Significant Change in Physical Examinations
Number of participants with clinical significant change in physical examinations will be assessed.
Measured: Up to approximately 20 days
Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Number of participants with clinical significant change in clinical laboratory test results will be assessed.
Measured: Up to approximately 20 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 20 days
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.
Measured: Up to approximately 20 days
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).
Measured: Up to approximately 20 days
Change From Baseline in Simpson-Angus Scale (SAS)
SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.
Measured: Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Cmax of Emraclidine
Measured: Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Cmax of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Time to Cmax (Tmax) of Emraclidine
Tmax of Emraclidine
Measured: Up to approximately 20 days
Time to Cmax (Tmax) of Metabolite (CV-0000364)
Tmax of Metabolite (CV-000036)
Measured: Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
AUCt of Emraclidine
Measured: Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
AUCt of Metabolite (CV-000036)
Measured: Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
AUCtau of Emraclidine
Measured: Up to approximately 20 days
Minimum plasma concentration (Cmin) of Emraclidine
Cmin of Emraclidine
Measured: Up to approximately 20 days
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
Cmin of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Average plasma concentration (Cavg) of Emraclidine
Cavg of Emraclidine
Measured: Up to approximately 20 days
Average plasma concentration (Cavg) of Metabolite (CV-0000364)
Cavg of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Emraclidine
MRCmax of Emraclidine calculated from Cmax
Measured: Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
MRCmax of Metabolite (CV-0000364) calculated from Cmax
Measured: Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
MRAUCtau of Emraclidine based on AUCtau
Measured: Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
MRAUCtau of Metabolite (CV-000036) based on AUCtau
Measured: Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Terminal phase elimination half-life of Emraclidine
Measured: Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)
Terminal phase elimination half-life of Metabolite (CV-000036)
Measured: Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Emraclidine
β of Emraclidine
Measured: Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
β of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Peak-to-trough ratio (PTR) of Emraclidine
PTR of Emraclidine
Measured: Up to approximately 20 days
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
PTR of Metabolite (CV-000036)
Measured: Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Emraclidine
RacCmax of Emraclidine
Measured: Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
RacCmax of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
RacAUCtau of Emraclidine
Measured: Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
RacAUCtau of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
CL/F of Emraclidine
Measured: Up to approximately 20 days
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Vz/F of Emraclidine
Measured: Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)
AUCtau of Metabolite (CV-0000364)
Measured: Up to approximately 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start8 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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
- 52 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
- NCT07219030
- Sponsor's protocol ID
- M25-904
- Status last verified
- Sep 2026
- First submitted
- 17 Oct 2025
- Last updated
- 15 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Emraclidine Following Multiple Ascending Oral Doses in Healthy Elderly Subjects
- ClinicalTrials.gov ID
- NCT07219030
- Acronym / sponsor ID
- M25-904
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-1231
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 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 is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Emraclidine or Placebo- Group 1 | Experimental | Drug: Emraclidine, Drug: PlaceboParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days |
| Emraclidine or Placebo- Group 2 | Experimental | Drug: Emraclidine, Drug: PlaceboParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days |
| Emraclidine or Placebo- Group 3 | Experimental | Drug: Emraclidine, Drug: PlaceboParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
| Emraclidine or Placebo- Group 4 | Experimental | Drug: Emraclidine, Drug: PlaceboParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
| Emraclidine or Placebo- Group 5 | Experimental | Drug: Emraclidine, Drug: PlaceboParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
| Emraclidine or Placebo- Group 6 | Experimental | Drug: Emraclidine, Drug: PlaceboParticipants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older 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 (3 listed)
- History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, genitourinary, immunological, hematologic, neurological or psychiatric disease or disorder, or any other uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
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 |
|---|---|---|
| EmraclidineOral tablets | Drug | Emraclidine or Placebo- Group 1, Emraclidine or Placebo- Group 2, Emraclidine or Placebo- Group 3, Emraclidine or Placebo- Group 4, Emraclidine or Placebo- Group 5, Emraclidine or Placebo- Group 6 |
| PlaceboOral tablets | Drug | Emraclidine or Placebo- Group 1, Emraclidine or Placebo- Group 2, Emraclidine or Placebo- Group 3, Emraclidine or Placebo- Group 4, Emraclidine or Placebo- Group 5, Emraclidine or Placebo- Group 6 |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 50 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 Clinical Significant Change From Baseline in Vital Sign Measurements
Time frame: Up to approximately 20 days
Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)
Time frame: Up to approximately 20 days
12-lead resting ECG will be recorded.
Number of Participants with Clinical Significant Change in Physical Examinations
Time frame: Up to approximately 20 days
Number of participants with clinical significant change in physical examinations will be assessed.
Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to approximately 20 days
Number of participants with clinical significant change in clinical laboratory test results will be assessed.
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately 20 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.
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to approximately 20 days
AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Time frame: Up to approximately 20 days
BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).
Change From Baseline in Simpson-Angus Scale (SAS)
Time frame: Up to approximately 20 days
SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Up to approximately 20 days
Cmax of Emraclidine
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Cmax of Metabolite (CV-0000364)
Time to Cmax (Tmax) of Emraclidine
Time frame: Up to approximately 20 days
Tmax of Emraclidine
Time to Cmax (Tmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Tmax of Metabolite (CV-000036)
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Time frame: Up to approximately 20 days
AUCt of Emraclidine
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
Time frame: Up to approximately 20 days
AUCt of Metabolite (CV-000036)
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Time frame: Up to approximately 20 days
AUCtau of Emraclidine
Minimum plasma concentration (Cmin) of Emraclidine
Time frame: Up to approximately 20 days
Cmin of Emraclidine
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Cmin of Metabolite (CV-0000364)
Average plasma concentration (Cavg) of Emraclidine
Time frame: Up to approximately 20 days
Cavg of Emraclidine
Average plasma concentration (Cavg) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Cavg of Metabolite (CV-0000364)
Metabolite to Parent Ratio (MRCmax) of Emraclidine
Time frame: Up to approximately 20 days
MRCmax of Emraclidine calculated from Cmax
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
MRCmax of Metabolite (CV-0000364) calculated from Cmax
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
Time frame: Up to approximately 20 days
MRAUCtau of Emraclidine based on AUCtau
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
MRAUCtau of Metabolite (CV-000036) based on AUCtau
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Time frame: Up to approximately 20 days
Terminal phase elimination half-life of Emraclidine
Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
Terminal phase elimination half-life of Metabolite (CV-000036)
Apparent terminal phase elimination constant (β) of Emraclidine
Time frame: Up to approximately 20 days
β of Emraclidine
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
β of Metabolite (CV-0000364)
Peak-to-trough ratio (PTR) of Emraclidine
Time frame: Up to approximately 20 days
PTR of Emraclidine
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
PTR of Metabolite (CV-000036)
Accumulation ratio for Cmax (RacCmax) of Emraclidine
Time frame: Up to approximately 20 days
RacCmax of Emraclidine
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
RacCmax of Metabolite (CV-0000364)
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
Time frame: Up to approximately 20 days
RacAUCtau of Emraclidine
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
RacAUCtau of Metabolite (CV-0000364)
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Time frame: Up to approximately 20 days
CL/F of Emraclidine
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Time frame: Up to approximately 20 days
Vz/F of Emraclidine
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
AUCtau of Metabolite (CV-0000364)
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 15 Sep 2026.
- 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.
ABBVIE INC. study director
AbbVie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emraclidine in people with Healthy Volunteer, run by AbbVie at 5 sites 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 3 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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 50 days). The study lists 37 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 Sep 2026.