Tests AX251 long-acting injection in people with schizophrenia
Tests how the body handles AX251 injections at different doses in schizophrenia.
Plain-language title generated from the registry record
Registry title: Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia
Key facts
- Where
- Ahmedabad, Gandhinagar, and Nagar, IndiaSee the 4 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07484204, who can take part
Where in India
- DHS Multispeciality HospitalAhmedabad, IndiaTaking people
- Health HospitalAhmedabad, IndiaTaking people
- Divine Multispeciality HospitalGandhinagar, IndiaTaking people
- Ratandeep Multispeciality HospitalNagar, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Anxo Pharmaceutical Co., Ltd.
- Trial code
- NCT07484204
- Record updated
- 16 September 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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; 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.
Exclusion: Substance use disorder (including alcohol or benzodiazepines) within 180 days prior to screening, excluding caffeine and tobacco; 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; 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; 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; Severe renal impairment (estimated glomerular filtration rate <30 mL/min); History of syncope or significant orthostatic hypotension at screening; Clinically significant electrocardiogram abnormalities at screening; Acute psychosis posing imminent risk to self or others; Acute relapse of schizophrenia at screening.