Protocol CC100A CC100: Safety and Tolerability of Single Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Unsolicited Adverse Event Reports
研究概览
简要总结
The purpose of this study is to see if CC100, given by mouth, is safe and is tolerated in increasing doses. How long the drug remains in the body will also be calculated.
详细描述
Approximately 18 healthy subjects will be randomized to receive by mouth either 3 single increasing doses of CC100 or 1 dose of placebo and 2 increasing doses of CC100. Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose. Subjects are required to stay in the Clinic for approximately 24 hours following each dose. Subjects may choose to have an optional lumbar puncture following the 3rd dose of study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men must practice a reliable method of birth control during study and for 2 weeks following study. Women must be non-fertile or post-menopausal.
排除标准
- •Have serious or unstable illnesses as determined by the investigator.
- •Have current or a history of asthma, or severe drug allergies or pollen allergy.
- •Have used medications (except for calcium supplements or externally applied eye drops or antibiotics) within 30 days prior to dosing or are expected to use other medications during the study.
- •Have had serious infectious disease affecting the brain within the preceding 5 years; or have known or existing evidence of serious infection.
- •Have laboratory test values that are considered clinically significant as determined by the investigator.
- •Have ECG abnormalities that are clinically significant.
- •Have donated blood (a pint or more) or received an experimental drug within 30 days prior to dosing.
- •Have a history of chronic alcohol or drug abuse within the past 2 years.
研究组 & 干预措施
CC100 (3 single doses)
CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
干预措施: CC100 (Drug)
CC100 (2 single doses) & placebo(1 dose)
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
干预措施: CC100 (Drug)
CC100 (2 single doses) & placebo(1 dose)
CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.
干预措施: Placebo (Drug)
结局指标
主要结局
Unsolicited Adverse Event Reports
时间窗: Minimum of 24 hours after each dose.
Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.
次要结局
- Pharmacokinetics (PK)(0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100)
- Half-Life (t1/2)(0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100)