NCT01093859已完成早期 1 期
An Exploratory Phase 1 Study to Assess the Safety and Pharmacokinetics of PRX-105, Administered as a Single, Microdose, Intravenous Slow Bolus Injection to Healthy Volunteers
Protalix1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- PRX-105 plasma concentration
研究概览
简要总结
Exploratory phase 1, first in human, open label, non-randomized, single-dose study of PRX-105, administered intravenously by slow bolus injection to 10 healthy volunteers. The objective is to evaluate the pharmacokinetic profile of PRX-105 without any significant physiological effect in healthy volunteers after a single, intravenous microdose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 18-45 (inclusive) years.
- •Body Mass Index (BMI) 19 to 29 kg/m2 (inclusive) and weighing at least 60 Kg and up to 90 kg.
- •Non-smoking (by declaration) for a period of at least 6 months prior to screening visit.
- •Blood pressure and heart rate within normal limits.
- •Electrocardiogram (ECG) with no clinically significant abnormalities.
排除标准
- •History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medication.
- •Current / previous occupational exposure to organophosphates or pesticides.
- •Previous receipt of any investigational butyrylcholinesterase product.
研究组 & 干预措施
PRX-105 Infusion
Experimental
干预措施: PRX-105 (Drug)
结局指标
主要结局
PRX-105 plasma concentration
时间窗: 0 to 48 hours after injection
Assessment of pharmacokinetics
次要结局
- Cardiovascular monitoring(0 to 48 hours after injection)
- Neurological examination(0 to 48 hours)
- Ophthalmic evaluation(0 to 8 hours)
研究者
研究点 (1)
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