SchizophreniaPhase 2/3NCT07722728

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

A Phase 2/3 study testing 30 mg B2227, 70 mg B2227 and 150 mg B2227 in people with Schizophrenia, run by Bostal Drug Delivery Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: 30 mg B2227, 70 mg B2227 and 150 mg B2227
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: No sites listed yet
Study dates: Aug 2026to Dec 2027
Phase: Phase 2/3
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.
OR
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.
Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5.
The investigator is responsible for reviewing medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
Male participant is eligible to participate if he agrees to the following during the study period and for at least 12 weeks after the last dose of the study intervention.
Must agree not to plan to father a child or donate sperm for reproduction;
PLUS, EITHER:
Be abstinent from heterosexual intercourse as his preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR
Must agree to use contraception /barrier as detailed below:
A male participant must wear a condom when engaging in any activity that allows for the passage of ejaculate to another person.
Male participant should also be advised of the benefit for a female partner(s) to use a highly effective method of contraception as the condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
Participant has adequate hematologic, liver and renal functions at screening assessment.
a ANC ≥1500 cells/μL b Platelet count ≥100000 cells/μL c Haemoglobin ≥9.0 g/dL d White blood cell count (WBC) ≥ 4000 cells/μL e Creatinine clearance ≥ 60 mL/minute (using the Cockcroft-Gault Equation). f Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2 × upper limit of normal (ULN) g Total Bilirubin < 1.2 mg/dL h Alkaline phosphatase ≤ 2 ULN
Participant willing and able to adhere to the lifestyle restrictions specified in this protocol.
Participant who agrees to avoid drinking alcohol during the study.

Who cannot join

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.

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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).
Participants with major surgical procedure (including periodontal) within 28 days of investigational intervention dosing or plan to have major surgical procedure during the study.
Participants with current surgical or other non-healing wounds.
Participants who have participated in any clinical trial with another investigational drug or other investigational intervention within 90 days of enrolment.
Participant has donated blood or blood product or had substantial Loss of blood ≥ 350 mL (1 unit) within 90 days before enrolment in the study.
Participants with history of difficulty with donating blood or difficulty in accessibility of veins.
Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to starting the investigational intervention.
NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
Alcoholics (alcohol consumption of more than 14 units per week for men and more than 7 units per week for women, each unit equivalent to 360 mL of beer or 150 mL of wine or 45 mL of spirits with 40% alcohol content) and those who have a positive urine alcohol test.
Participants who have consumed tobacco-containing products (smoking, tobacco chewing, etc.), xanthine containing food, poppy seeds, and beverages (chocolates, tea, coffee, or cola drinks) or alcohol within 48.00 hours (02 days) prior to dosing.
Participants who have consumed grapefruit or its juice and cranberry juice within 96.00 hours (04 days) prior to dosing.
Participants currently smoking greater than or equal to 10 cigarettes or equivalent per day.
Participant unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the investigational intervention).
Participant with a documented medical history or current evidence of uncontrolled, clinically significant intercurrent medical condition(s), therapy, laboratory abnormality, or other circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

About this study

Official title: An Open-label, Randomized, Single-dose (Long-acting Injectable) or Multiple-dose (Oral) Clinical Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With Schizophrenia

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
Being tested: 30 mg B2227, 70 mg B2227, 150 mg B2227, Vraylar® 1.5 mg, Vraylar® 3.0 mg
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

30 mg B2227Drug
Single-dose; Subcutaneous
70 mg B2227Drug
Single-dose; Subcutaneous
150 mg B2227Drug
Single-dose; Subcutaneous
Vraylar® 1.5 mgDrug
Multiple-dose, Oral
Vraylar® 3.0 mgDrug
Multiple-dose, Oral
Vraylar® 4.5 mgDrug
Multiple-dose, Oral
Vraylar® 6.0 mgDrug
Multiple-dose, Oral

Study groups in NCT07722728
Study group	Role	What they receive
1.5 mg Vraylar®	Experimental	Not described Receives: Drug: Vraylar® 1.5 mg
3.0 mg Vraylar®	Experimental	Not described Receives: Drug: Vraylar® 3.0 mg
4.5 mg Vraylar®	Experimental	Not described Receives: Drug: Vraylar® 4.5 mg
6 mg Vraylar®	Experimental	Not described Receives: Drug: Vraylar® 6.0 mg
B2227 30 mg	Experimental	Not described Receives: Drug: 30 mg B2227
B2227 70 mg	Experimental	Not described Receives: Drug: 70 mg B2227
B2227 150 mg	Experimental	Not described Receives: Drug: 150 mg B2227

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Measured: Pre-dose to 190 days post-dose
Tmax
Measured: Pre-dose to 190 days post-dose
AUC0-last
Measured: Pre-dose to 190 days post-dose
AUC0-infinity
Measured: Pre-dose to 190 days post-dose
T1/2
Measured: Pre-dose to 190 days post-dose
Kel
Measured: Pre-dose to 190 days post-dose
Vd/F
Measured: Pre-dose to 190 days post-dose
MRT
Measured: Pre-dose to 190 days post-dose
AUC_%Extrap_obs
Measured: Pre-dose to 190 days post-dose
Cmax,ss
Measured: Pre-dose to 57 days post-dose
Cmin,ss
Measured: Pre-dose to 57 days post-dose
Cavg,ss
Measured: Pre-dose to 57 days post-dose
AUC24h
Measured: Pre-dose to 57 days post-dose
Fluctuation
Measured: Pre-dose to 57 days post-dose
Swing
Measured: Pre-dose to 57 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2026Dec 2027

First posted23 Jul 2026
Study startAug 2026 (estimated)
Primary completionAug 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07722728
Sponsor's protocol ID: 0513-25
Status last verified: Jul 2026
First submitted: 15 Jul 2026
Last updated: 23 Jul 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Single-dose (Long-acting Injectable) or Multiple-dose (Oral) Clinical Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of B2227 Extended-Release Injectable Suspension and Vraylar® in Participants With Schizophrenia
ClinicalTrials.gov ID: NCT07722728
Acronym / sponsor ID: 0513-25
Conditions: Schizophrenia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: Bostal Drug Delivery Co., LtdIndustry (pharma, biotech, devices)
Study start: Aug 2026 (estimated)
Primary completion: Aug 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 23 Jul 2026 (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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (29 listed)

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.

Key exclusion criteria (30 listed)

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.

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
30 mg B2227Single-dose; Subcutaneous	Drug	B2227 30 mg
70 mg B2227Single-dose; Subcutaneous	Drug	B2227 70 mg
150 mg B2227Single-dose; Subcutaneous	Drug	B2227 150 mg
Vraylar® 1.5 mgMultiple-dose, Oral	Drug	1.5 mg Vraylar®
Vraylar® 3.0 mgMultiple-dose, Oral	Drug	3.0 mg Vraylar®
Vraylar® 4.5 mgMultiple-dose, Oral	Drug	4.5 mg Vraylar®
Vraylar® 6.0 mgMultiple-dose, Oral	Drug	6 mg Vraylar®

Primary outcome

Cmax
Time frame: Pre-dose to 190 days post-dose
Tmax
Time frame: Pre-dose to 190 days post-dose
AUC0-last
Time frame: Pre-dose to 190 days post-dose
AUC0-infinity
Time frame: Pre-dose to 190 days post-dose
T1/2
Time frame: Pre-dose to 190 days post-dose
Kel
Time frame: Pre-dose to 190 days post-dose
Vd/F
Time frame: Pre-dose to 190 days post-dose
MRT
Time frame: Pre-dose to 190 days post-dose
AUC_%Extrap_obs
Time frame: Pre-dose to 190 days post-dose
Cmax,ss
Time frame: Pre-dose to 57 days post-dose
Cmin,ss
Time frame: Pre-dose to 57 days post-dose
Cavg,ss
Time frame: Pre-dose to 57 days post-dose
AUC24h
Time frame: Pre-dose to 57 days post-dose
Fluctuation
Time frame: Pre-dose to 57 days post-dose
Swing
Time frame: Pre-dose to 57 days post-dose

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 23 Jul 2026.

Related trials for Schizophrenia

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A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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Not yet recruitingPhase 1
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing 30 mg B2227, 70 mg B2227 and 150 mg B2227 in people with Schizophrenia, run by Bostal Drug Delivery Co., Ltd.

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 29 inclusion and 30 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

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?

Cmax (time frame: Pre-dose to 190 days post-dose). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07722728.

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 23 Jul 2026.