An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Concentration of IZD174 in cerebrospinal fluid
研究概览
简要总结
Single center, open-label, intra-individual dose-escalation study in subjects with mild/moderate Parkinson's Disease
详细描述
After assessing eligibility during a screening period of up to 4 weeks, up to 6 subjects will be included.
Subjects will check into the clinic one day prior to dosing (Day -1). To evaluate and compare drug exposure levels in plasma and CSF, plasma and CSF will be serially sampled over a period of 36 hours. Subjects will be discharged from the clinic on Day 5 after all required study procedures are completed and if medically justified.
Subjects will return to the clinic approximately 1 week after discharge from the clinic for a follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a man or woman aged between 45 and 75, inclusive.
- •Documented clinically established diagnosis of Parkinson's Disease, Hoehn & Yahr stage 1 to 3 and Montreal Cognitive Assessment greater or equal than
- •Diagnosis of Parkinson's Disease consistent wit MDS Research Criteria for the Diagnosis of Parkinson's Disease must include bradykinesia with sequence effect, and motor asymmetry (especially if no rest tremor). Diagnosis has to be made less than 3 years prior to Screening.
- •The subject understands the nature and purpose of the study, including possible risks and side effects, and i willing and able to comply with all compulsory stud procedures and provides signed and dated written informed consent (in accordance with local regulations) prior to any study procedures being performed.
排除标准
- •The subject used any NSAIDs, steroids, colchicine or anti-IL-1 inhibitors within 7 days prior to Day
- •The subject received any investigational drugs within 4 weeks or 5 half-lives (whichever is longer), prior to Day
- •The subject had an active systemic infection (other than common cold) within 2 weeks prior to Day
- •The subject has a history of severe hypersensitivity to previous drugs.
- •The subject has any severe, progressive or uncontrolled medical condition at Screening or on Day -1 that in the judgment of the investigator prevents the subject from participating in the study.
研究组 & 干预措施
IZD174
Intra subject dose escalation of IZD174
干预措施: IZD174 (Drug)
结局指标
主要结局
Concentration of IZD174 in cerebrospinal fluid
时间窗: Pre-dose to 36 hours post dose
CSF PK profile following an intra-individual dose escalation of IZD174
Concentration of IZD174 in plasma
时间窗: Pre-dose to 36 hours post dose
Plasma PK profile following an intra-individual dose escalation of IZD174
Ratio of IZD174 concentration in plasma to CSF
时间窗: Pre-dose to 36 hours post dose
CSF to plasma concentration ratio at each time point
次要结局
- Inhibition of Interleukin-1 beta secretion in ex-vivo stimulated whole blood(Pre-dose to 36 hours post dose)
- Incidence of Treatment-Emergent Adverse Events(Day 0 to Day 10)