NL-OMON49465已完成不适用
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. - CS0339 Inflazome
Inflazome Limited0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The subject is a man or woman aged between 45 and 69, inclusive.
- •Documented clinically established diagnosis of Parkinson*s Disease, Hoehn &
- •Yahr stage 1 to 3 and Montreal Cognitive Assessment greater or equal than 26.
- •Diagnosis of Parkinson*s Disease consistent with 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.
- •Patients that receive treatment for Parkinson*s Disease should be on a stable
- •dose level and regimen for at least 14 days prior to study drug administration
- •and should have the intention to stay on this regimen throughout the study.
- •The subject understands the nature and purpose of the study, including possible
- •risks and side effects, and is willing and able to comply with all compulsory
- •study procedures and provides signed and dated written informed consent (in
- •accordance with local regulations) prior to any study procedures being
排除标准
- •The subject used any NSAIDs, steroids, colchicine or anti-IL-1 inhibitors
- •within 7 days prior to Day 1.
- •The subject received any investigational drugs within 4 weeks or 5 half-lives
- •(whichever is longer), prior to Day 1.
- •The subject had an active systemic infection (other than common cold) within 2
- •weeks prior to Day 1.
- •The subject has a history of severe hypersensitivity to previous drugs.
研究者
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