SchizophreniaPhase 1NCT07484204
Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia
A Phase 1 study testing AX251 LAI 45 mg, AX251 LAI 90 mg and AX251 LAI 135 mg in people with Schizophrenia, run by Anxo Pharmaceutical Co., Ltd. at 4 sites in India.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- AX251 LAI 45 mg, AX251 LAI 90 mg and AX251 LAI 135 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesIndia
- Study dates
- 14 Sep 2026to Jul 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 18 to 65 years (inclusive).
- clinical diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria, at screening.
- Body Mass Index (BMI) 18.5-35.0 kg/m² at screening.
- Clinical Global Impression-Severity (CGI-S) score ≤4 at screening.
- Positive and Negative Syndrome Scale (PANSS) total score ≤75 at screening.
- Clinically stable schizophrenia on current antipsychotic medication other than cariprazine for at least 3 months prior to screening.
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- Subjects must not be taking more than two antipsychotic medications.
- Able to remain at the study site for 7 days following AX251 LAI injection.
- Judged by the investigator to be physically and mentally able to participate in the study based on clinical evaluation, physical examination, electrocardiogram (ECG), and laboratory assessments.
- Willing and able to comply with study procedures.
- Agrees to use protocol-defined contraception during the study.
- Previous tolerability to oral cariprazine (1.5-6 mg) or willingness to undergo a short oral tolerability test (2-7 days) followed by washout before study drug administration.
Who cannot join
- Diagnosis of psychiatric disorders other than schizophrenia according to DSM-5-TR (e.g., schizoaffective disorder, major depressive disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia, mild neurocognitive disorder, or personality disorders), except caffeine- or tobacco-related disorders.
- Substance use disorder (including alcohol or benzodiazepines) within 180 days prior to screening, excluding caffeine and tobacco.
- History of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia, akathisia, or extrapyramidal symptoms.
- Clinically significant cardiovascular, hematologic, metabolic, hepatic, renal, immunologic, or neurological disease that may interfere with study participation.
- Severe hepatic impairment (Child-Pugh Class C) at screening.
- Uncontrolled hypertension.
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- Clinically significant electrocardiogram abnormalities at screening.
- Severe renal impairment (estimated glomerular filtration rate <30 mL/min).
- History of syncope or significant orthostatic hypotension at screening.
- Failure to complete required washout period (≥5 half-lives) for prohibited medications before administration of AX251 LAI.
- Current treatment with other antipsychotic long-acting injectable (LAI) therapies.
- Electroconvulsive therapy within 60 days prior to screening.
- Acute psychosis posing imminent risk to self or others.
- Acute relapse of schizophrenia at screening.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India4 sites, 4 recruiting
- Recruiting
DHS Multispeciality Hospital
Ahmedabad
Dr. Nehalkumar Shah, +91 97274 50700, doctornehal@gmail.com
- Recruiting
Health Hospital
Ahmedabad
Dr. Ramashanker Yadav, +919978770715, drmalaypatel.research@gmail.com
- Recruiting
Divine Multispeciality Hospital
Gandhinagar
Dr. Malay Patel, +91 75678 48362, rmalaypatel.research@gmail.com
- Recruiting
Ratandeep Multispeciality Hospital
Nagar
Vaishal Vora, +91 98253 67148, vaishal.vora@ratandeepmsh.com
About this study
Official title: An Open-label, Multicenter Study to Determine the Pharmacokinetics, Safety, and Tolerability of AX251 Long-Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI.
- Conditions
- Schizophrenia
- Being tested
- AX251 LAI 45 mg, AX251 LAI 90 mg, AX251 LAI 135 mg, AX251 LAI 180 mg
- Keywords
- AX251
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AX251 LAI 45 mgDrug
Cariprazine 45 mg
AX251 LAI 90 mgDrug
Cariprazine 90 mg
AX251 LAI 135 mgDrug
Cariprazine 135 mg
AX251 LAI 180 mgDrug
Cariprazine 180 mg
| Study group | Role | What they receive |
|---|---|---|
| AX251 LAI 45 mg | Experimental | AX251 LAI 45mg Receives: Drug: AX251 LAI 45 mg |
| AX251 LAI 90mg | Experimental | AX251 LAI 90mg Receives: Drug: AX251 LAI 90 mg |
| AX251 LAI 135mg | Experimental | AX251 LAI 135mg Receives: Drug: AX251 LAI 135 mg |
| AX251 LAI 180mg | Experimental | AX251 LAI 180mg Receives: Drug: AX251 LAI 180 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter
Maximum observed serum concentration of cariprazine and its metabolites desmethyl-cariprazine (DCAR) and didesmethyl-cariprazine (DDCAR) following a single dose of AX251 long-acting injectable (LAI).
Measured: Day 1 pre-dose and 1, 2, 3, 4, 8, 12, and 24 hours post-dose. Days 3, 5, 7, 14, 21, 28, 42, 56, and 70
Secondary outcomes (1)
Safety: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and proportion of participants experiencing treatment-emergent adverse events and serious adverse events during the study.
Measured: Baseline to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start14 Sep 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anxo Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484204
- Sponsor's protocol ID
- AX251-01
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study to Determine the Pharmacokinetics, Safety, and Tolerability of AX251 Long-Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07484204
- Acronym / sponsor ID
- AX251-01
- Conditions
- Schizophrenia
- Keywords
- AX251
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Anxo Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Mar 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 purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AX251 LAI 45 mg | Experimental | Drug: AX251 LAI 45 mgAX251 LAI 45mg |
| AX251 LAI 90mg | Experimental | Drug: AX251 LAI 90 mgAX251 LAI 90mg |
| AX251 LAI 135mg | Experimental | Drug: AX251 LAI 135 mgAX251 LAI 135mg |
| AX251 LAI 180mg | Experimental | Drug: AX251 LAI 180 mgAX251 LAI 180mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects aged 18 to 65 years (inclusive).
- clinical diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria, at screening.
- Body Mass Index (BMI) 18.5-35.0 kg/m² at screening.
- Clinical Global Impression-Severity (CGI-S) score ≤4 at screening.
- Positive and Negative Syndrome Scale (PANSS) total score ≤75 at screening.
Key exclusion criteria (14 listed)
- Diagnosis of psychiatric disorders other than schizophrenia according to DSM-5-TR (e.g., schizoaffective disorder, major depressive disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia, mild neurocognitive disorder, or personality disorders), except caffeine- or tobacco-related disorders.
- Substance use disorder (including alcohol or benzodiazepines) within 180 days prior to screening, excluding caffeine and tobacco.
- History of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia, akathisia, or extrapyramidal symptoms.
- Clinically significant cardiovascular, hematologic, metabolic, hepatic, renal, immunologic, or neurological disease that may interfere with study participation.
- Severe hepatic impairment (Child-Pugh Class C) at screening.
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 |
|---|---|---|
| AX251 LAI 45 mgCariprazine 45 mg | Drug | AX251 LAI 45 mg |
| AX251 LAI 90 mgCariprazine 90 mg | Drug | AX251 LAI 90mg |
| AX251 LAI 135 mgCariprazine 135 mg | Drug | AX251 LAI 135mg |
| AX251 LAI 180 mgCariprazine 180 mg | Drug | AX251 LAI 180mg |
Primary outcome
Pharmacokinetic Parameter
Time frame: Day 1 pre-dose and 1, 2, 3, 4, 8, 12, and 24 hours post-dose. Days 3, 5, 7, 14, 21, 28, 42, 56, and 70
Maximum observed serum concentration of cariprazine and its metabolites desmethyl-cariprazine (DCAR) and didesmethyl-cariprazine (DDCAR) following a single dose of AX251 long-acting injectable (LAI).
1 secondary outcome
Safety: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to Day 70
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 16 Sep 2026.
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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.
4 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 AX251 LAI 45 mg, AX251 LAI 90 mg and AX251 LAI 135 mg in people with Schizophrenia, run by Anxo Pharmaceutical Co., Ltd. at 4 sites in India.
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 12 inclusion and 14 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 16 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 4 sites in India. 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 Mico Hsu (886-5716223, mico_hsu@anxo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameter (time frame: Day 1 pre-dose and 1, 2, 3, 4, 8, 12, and 24 hours post-dose. Days 3, 5, 7, 14, 21, 28, 42, 56, and 70). 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 16 Sep 2026.