NL-OMON53497已完成不适用
A phase 1b study to evaluate the pharmacokinetics and safety of CLE-600 in patients with Parkinson*s disease - CLE-600 PK and safety study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- •1. Sex : male or female; females must be of nonchildbearing potential or
- •postmenopausal.
- •2. Age : 40 to 80 years, inclusive, at screening.
- •3. Body mass index (BMI) : 18.0 to 32.0 kg/m2, inclusive, at screening.
- •4. Weight : >=50 kg, at screening.
- •5. Status : PD patients (diagnosed according to UK PD Society Brain Bank
- •Further criteria apply
排除标准
- •1. Previous participation in the current study.
- •2. Employee of ICON or the Sponsor.
- •3. History of alcohol abuse or drug addiction within the last year (including
- •soft drugs like cannabis products), except for tobacco use disorder.
- •4. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
- •[including ecstasy], cannabinoids, barbiturates, benzodiazepines, and alcohol)
- •at screening or admission (Day 1 for Part A and Day -1 for Part B) to the
- •clinical research center. For cannabinoids, in case of a positive screen the
- •Investigator should decide whether this is related to medical or recreational
- •use (then subject may be included) or to drug addiction (then subject should be
- •5. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
- •equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
- •Further criteria apply
研究者
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