A Study to Investigate Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With Schizophrenia

NCT07722728 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 0513-25
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is to evaluate the pharmacokinetic profile of B2227 Extended-Release Injectable Suspension against Vraylar® Cariprazine capsules of AbbVie Inc. in participants with schizophrenia.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (15)

• Cmax

  Pre-dose to 190 days post-dose

• Tmax

  Pre-dose to 190 days post-dose

• AUC0-last

  Pre-dose to 190 days post-dose

• AUC0-infinity

  Pre-dose to 190 days post-dose

• T1/2

  Pre-dose to 190 days post-dose

• Kel

  Pre-dose to 190 days post-dose

• Vd/F

  Pre-dose to 190 days post-dose

• MRT

  Pre-dose to 190 days post-dose

• AUC_%Extrap_obs

  Pre-dose to 190 days post-dose

• Cmax,ss

  Pre-dose to 57 days post-dose

• Cmin,ss

  Pre-dose to 57 days post-dose

• Cavg,ss

  Pre-dose to 57 days post-dose

• AUC24h

  Pre-dose to 57 days post-dose

• Fluctuation

  Pre-dose to 57 days post-dose

• Swing

  Pre-dose to 57 days post-dose

Study Arms (7)

1.5 mg Vraylar®

EXPERIMENTAL

Drug: Vraylar® 1.5 mg

3.0 mg Vraylar®

EXPERIMENTAL

Drug: Vraylar® 3.0 mg

4.5 mg Vraylar®

EXPERIMENTAL

Drug: Vraylar® 4.5 mg

6 mg Vraylar®

EXPERIMENTAL

Drug: Vraylar® 6.0 mg

B2227 30 mg

EXPERIMENTAL

Drug: 30 mg B2227

B2227 70 mg

EXPERIMENTAL

Drug: 70 mg B2227

B2227 150 mg

EXPERIMENTAL

Drug: 150 mg B2227

Interventions

30 mg B2227 DRUG

Single-dose; Subcutaneous

B2227 30 mg

Vraylar® 1.5 mg DRUG

Multiple-dose, Oral

1.5 mg Vraylar®

Vraylar® 3.0 mg DRUG

Multiple-dose, Oral

3.0 mg Vraylar®

70 mg B2227 DRUG

Single-dose; Subcutaneous

B2227 70 mg

150 mg B2227 DRUG

Single-dose; Subcutaneous

B2227 150 mg

Vraylar® 4.5 mg DRUG

Multiple-dose, Oral

4.5 mg Vraylar®

Vraylar® 6.0 mg DRUG

Multiple-dose, Oral

6 mg Vraylar®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant and/or their legally acceptable representative (LAR) must sign an informed consent form (ICF) indicating that the participant understands the purpose of and procedures required for the study as described in Section 10.1.3 and in this protocol and is willing to participate in the study.
• Male or female participant with age of 18-65 years (both inclusive) at the time of signing the informed consent.
• Participant has a body mass index (BMI) within the range 18.50 to 30.00 kg/m2 (inclusive).
• Participant diagnosed with schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria.
• Participant with a Clinical Global Impression-Severity of Illness (CGI-S) Score of ≤ 4 at screening.
• Participant with Positive and Negative syndrome-scale (PANSS) total score ≤75 at screening.
• Schizophrenic participants who are clinically stable on their current antipsychotic medication other than cariprazine, for a duration of at least 8 weeks prior to screening.
• Note: Participants must NOT be taking \> 1 antipsychotic medication for their disease.
• Participant who has previously received and tolerated oral cariprazine 3 mg or higher dose (no discontinuations due to AEs attributable to cariprazine).
• Contraceptive use by participant or participant's partner(s) should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4: Contraceptive and Barrier Guidance.
• Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4: Contraceptive and Barrier Guidance during the study period and for at least 12 weeks after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention.
• A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their own use during the recommended period of contraception. A WOCBP agrees to seek advice about donation and cryopreservation of germ cells.
• A WOCBP must have a negative highly sensitive pregnancy test (serum) at screening assessment and a negative highly sensitive pregnancy test (urine) on day 1 prior to the first dose of investigational intervention, but no more than 7 days before the first dose of the study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

You may not qualify if:

• Participant has a known clinically significant (≥Grade 3) allergies, hypersensitivity, or intolerance to any of the study interventions (or related class of drugs) or components/ excipients thereof \[refer to the investigator's brochure (IB)/US-prescribing information (USPI) 1,2\], or drug or other allergies that in the opinion of the investigator or medical monitor, contraindicate participation in the study.
• Participant has contraindications to the use of B2227, cariprazine per local prescribing information.
• Participants currently in acute, manic episodes of schizophrenia, as assessed by the Investigator.
• Participants with history of or a current DSM-5-TR (or later) diagnosis of concurrent mental disorder besides schizophrenia (e.g., schizoaffective-disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder).
• Participants who have attempted suicide within 12 months prior to screening based on history, or who had suicidal ideation within 2 months prior to screening based on C-SSRS (Columbia-Suicide Severity Rating Scale), or who exhibit violent tendencies/behavior, as clinically assessed by the investigator.
• Participants with history or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, Parkinson's disease, epilepsy or other seizure disorders, cognitive and motor impairment, pathological gambling, dysphagia or other compulsive behavior.
• Participants with a prior personal or family history of dystonic reactions to medications.
• Participants with clinically significant dyslipidemia as per Investigator's discretion.
• Participants with a history of syncope or a presence of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more within 3 minutes of standing from supine) at screening.
• Participants with known history or presence of any uncontrolled systemic disease (e.g., cardiovascular disease, cerebrovascular disease, diabetes mellitus, etc.) as per clinical judgment of clinical investigator.
• Participants who are on concurrent treatment with other anti-psychotic Long-acting Injection (LAIs).
• Participants who have received concomitant medications that are strong CYP3A4 inhibitors or CYP3A4 inducers within 14 days prior to study drug administration (or within five halflives since the last drug administration, whichever is greater), or is expected to require such treatment during the study. Refer Table 6-2.
• Participants with any other medical condition or serious inter-current illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness other than schizophrenia /social situations that would limit adherence to study requirements.
• Any other condition(s) which could significantly interfere with protocol compliance.
• Participants found positive for urine screen for drugs of abuse (except for benzodiazepine, which is a permissible medication if supported by prescription).

Sponsors & Collaborators

• Bostal Drug Delivery Co., Ltd: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07