NCT07145918 · AbbVie
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
What this study is about
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self.
View original scientific description
Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia Emraclidine is an investigational drug being developed for the treatment of schizophrenia.
Interventions
DRUG
Emraclidine
Oral Tablets
DRUG
Placebo
Oral Tablets
Primary outcome measures
Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 74 days
An adverse event (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. The investigator assesses the relationship of each event to the use of study.
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Up to approximately 24 days
Cmax of Emraclidine
Part A Only-Time to Cmax (Tmax) of Emraclidine
Time frame: Up to approximately 24 days
Tmax of Emraclidine
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Time frame: Up to approximately 24 days
AUCt of Emraclidine
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Time frame: Up to approximately 24 days
AUCtau of Emraclidine
Part A Only-Maximum metabolite concentration (MRCmax) of Emraclidine
Time frame: Up to approximately 21 days
MRCmax of Emraclidine
Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Emraclidine
Time frame: Up to approximately 21 days
MRAUCtau of Emraclidine
Part A Only- Minimum plasma concentration (Cmin) of Emraclidine
Time frame: Up to approximately 21 days
Cmin of Emraclidine
Part A Only-Average plasma concentration (Cavg) of Emraclidine
Time frame: Up to approximately 21 days
Cavg of Emraclidine
Part A Only- Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Time frame: Up to approximately 21 days
Terminal phase elimination half-life of Emraclidine
Part A Only-Terminal elimination rate constant (λz) of Emraclidine
Time frame: Up to approximately 21 days
λz of Emraclidine
Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Time frame: Up to approximately 21 days
CL/F of Emraclidine
Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Time frame: Up to approximately 21 days
Vz/F of Emraclidine
Part A Only-Peak-to-trough ratio (PTR) of Emraclidine
Time frame: Up to approximately 21 days
PTR of Emraclidine
Part A Only- Accumulation ratio for Cmax (RacCmax) of Emraclidine
Time frame: Up to approximately 21 days
RacCmax of Emraclidine
Part A Only-Accumulation ratio for AUCta (RacAUCtau) of Emraclidine
Time frame: Up to approximately 21 days
RacAUCta of Emraclidine
Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 24 days
Cmax of Metabolite (CV-0000364)
Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 24 days
Tmax of Metabolite (CV-000036)
Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)
Time frame: Up to approximately 24 days
AUCtau of Metabolite (CV-000036)
Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
Time frame: Up to approximately 24 days
AUCt of Metabolite (CV-000036)
Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)
Time frame: Up to approximately 21 days
MRCmax of Metabolite (CV-000036)
Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)
Time frame: Up to approximately 21 days
MRAUCtau of Metabolite (CV-000036)
Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Up to approximately week 6
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- BMI within 18 to 40 kg/m2 (inclusive of both values), and body weight \> 50 kg (110 lbs).
- (Part A only): Positive and Negative Syndrome Scale (PANSS) total score \< 80 at Screening and at Baseline
- (Part B only): Participant experiencing an acute exacerbation of psychotic symptoms with onset less than 2 months prior to Screening
- (Part B only): Participant must have a PANSS total score from 80 to 120, inclusive, at Screening and at Baseline
- (Part B only): Participant MUST have a score of ≥ 4 (moderate or greater) for ≥ 2 of the following PANSS Positive Scale items at Screening and at Baseline
- (Part B only): Participant must have a Clinical Global Impression of Severity (CGIS) score ≥ 4 (at least moderately ill) at Screening and Baseline
Exclusion criteria
- Any primary DSM-5 disorder other than schizophrenia (current nicotine use disorder and caffeine use disorder are allowed) within 12 months before Screening.
- History of clozapine exposure.
Where
- Little Rock, Arkansas
- Garden Grove, California
- Glendale, California
- Gaithersburg, Maryland
- Marlton, New Jersey
- Austin, Texas
- Richardson, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations