A Randomised, Double-blind, Placebo-controlled Study of the Safety, Pharmacokinetics and Exploratory Pharmacodynamics of AUT00206 for 28 Days as Adjunctive Therapy in Patients With Recently Diagnosed Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
研究概览
简要总结
This study will investigate the safety, tolerability, PK and PD profile of AUT00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. The subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. Because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose AUT00206 800 mg BD
AUT00206 800mg twice daily for 28 days
干预措施: AUT00206 (Drug)
Placebo
Placebo to match AUT00206 twice daily for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events over 28 days treatment of AUT00206 compared to Placebo
时间窗: 28 days
Plasma concentrations of AUT00206
时间窗: 28 days
次要结局
未报告次要终点