Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:06 AM
Study NCT ID:
NCT07484204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Parameter', 'timeFrame': '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', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline to Day 70', 'description': 'Number and proportion of participants experiencing treatment-emergent adverse events and serious adverse events during the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AX251'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 18 to 65 years (inclusive).\n* 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.\n* Body Mass Index (BMI) 18.5-35.0 kg/m² at screening.\n* Clinical Global Impression-Severity (CGI-S) score ≤4 at screening.\n* Positive and Negative Syndrome Scale (PANSS) total score ≤75 at screening.\n* Clinically stable schizophrenia on current antipsychotic medication other than cariprazine for at least 3 months prior to screening.\n* Subjects must not be taking more than two antipsychotic medications.\n* Able to remain at the study site for 7 days following AX251 LAI injection.\n* 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.\n* Willing and able to comply with study procedures.\n* Agrees to use protocol-defined contraception during the study.\n* 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.\n\nExclusion Criteria:\n\n* 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.\n* Substance use disorder (including alcohol or benzodiazepines) within 180 days prior to screening, excluding caffeine and tobacco.\n* History of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia, akathisia, or extrapyramidal symptoms.\n* Clinically significant cardiovascular, hematologic, metabolic, hepatic, renal, immunologic, or neurological disease that may interfere with study participation.\n* Severe hepatic impairment (Child-Pugh Class C) at screening.\n* Uncontrolled hypertension.\n* Clinically significant electrocardiogram abnormalities at screening.\n* Severe renal impairment (estimated glomerular filtration rate \\<30 mL/min).\n* History of syncope or significant orthostatic hypotension at screening.\n* Failure to complete required washout period (≥5 half-lives) for prohibited medications before administration of AX251 LAI.\n* Current treatment with other antipsychotic long-acting injectable (LAI) therapies.\n* Electroconvulsive therapy within 60 days prior to screening.\n* Acute psychosis posing imminent risk to self or others.\n* Acute relapse of schizophrenia at screening.'}, 'identificationModule': {'nctId': 'NCT07484204', 'briefTitle': 'Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anxo Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AX251-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AX251 LAI 45 mg', 'description': 'AX251 LAI 45mg', 'interventionNames': ['Drug: AX251 LAI 45 mg']}, {'type': 'EXPERIMENTAL', 'label': 'AX251 LAI 90mg', 'description': 'AX251 LAI 90mg', 'interventionNames': ['Drug: AX251 LAI 90 mg']}, {'type': 'EXPERIMENTAL', 'label': 'AX251 LAI 135mg', 'description': 'AX251 LAI 135mg', 'interventionNames': ['Drug: AX251 LAI 135 mg']}, {'type': 'EXPERIMENTAL', 'label': 'AX251 LAI 180mg', 'description': 'AX251 LAI 180mg', 'interventionNames': ['Drug: AX251 LAI 180 mg']}], 'interventions': [{'name': 'AX251 LAI 45 mg', 'type': 'DRUG', 'description': 'Cariprazine 45 mg', 'armGroupLabels': ['AX251 LAI 45 mg']}, {'name': 'AX251 LAI 90 mg', 'type': 'DRUG', 'description': 'Cariprazine 90 mg', 'armGroupLabels': ['AX251 LAI 90mg']}, {'name': 'AX251 LAI 135 mg', 'type': 'DRUG', 'description': 'Cariprazine 135 mg', 'armGroupLabels': ['AX251 LAI 135mg']}, {'name': 'AX251 LAI 180 mg', 'type': 'DRUG', 'description': 'Cariprazine 180 mg', 'armGroupLabels': ['AX251 LAI 180mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagar', 'country': 'India', 'contacts': [{'name': 'Vaishal Vora', 'role': 'CONTACT', 'email': 'vaishal.vora@ratandeepmsh.com', 'phone': '+91 98253 67148'}], 'facility': 'Ratandeep Multispeciality Hospital', 'geoPoint': {'lat': 27.42397, 'lon': 77.09922}}], 'centralContacts': [{'name': 'Mico Hsu', 'role': 'CONTACT', 'email': 'mico_hsu@anxo.com.tw', 'phone': '886-5716223'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anxo Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}