NCT07484204尚未招募1 期
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
Anxo Pharmaceutical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Pharmacokinetic Parameter
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
AX251 LAI 45 mg
Experimental
AX251 LAI 45mg
干预措施: AX251 LAI 45 mg (Drug)
AX251 LAI 90mg
Experimental
AX251 LAI 90mg
干预措施: AX251 LAI 90 mg (Drug)
AX251 LAI 135mg
Experimental
AX251 LAI 135mg
干预措施: AX251 LAI 135 mg (Drug)
AX251 LAI 180mg
Experimental
AX251 LAI 180mg
干预措施: AX251 LAI 180 mg (Drug)
结局指标
主要结局
Pharmacokinetic Parameter
时间窗: 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).
次要结局
- Safety: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Baseline to Day 70)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
1 期
A Study to Evaluate Safety and Efficacy of OLX72021 in Healthy Males With Androgenetic AlopeciaNCT07327359Olix Pharmaceuticals, Inc.158
招募中
2 期
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease2025-521752-26-00Adarx Pharmaceuticals Inc.7
招募中
2 期
A Trial to Determine The Safety and Efficacy of CC-92480 Alone and When Combined With Dexamethasone in People Who Have Myeloma That is Not Responsive After Treatment or Who Had Myeloma Which Has Returned After a Period of Treatment2023-508727-12-00Celgene Corp.46
已完成
1 期
A Study Comparing LTG-001 SDD Formulation To LTG-001 Crystalline Immediate Release Tablets In Healthy ParticipantsNCT07341152Latigo Biotherapeutics14
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/10/1000mg in Healthy VolunteersType 2 DiabetesNCT07304700Chong Kun Dang Pharmaceutical30