A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Neurop Inc.
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of adverse events as a measure of safety and tolerability
研究概览
简要总结
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
详细描述
NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects aged 18 to 55 years
- •Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
- •If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.
排除标准
- •Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
- •Recent history (within 2 yrs) or current tobacco use.
研究组 & 干预措施
NP10679 50 mg
NP10679 50 mg intravenous infusion on day 1
干预措施: NP10679 (Drug)
NP10679 15 mg
NP10679 15 mg intravenous infusion on day 1
干预措施: NP10679 (Drug)
Placebo
Placebo intravenous 30 minute infusion on day 1
干预措施: Placebo (Drug)
NP10679 5 mg
NP10679 5 mg intravenous infusion on day 1
干预措施: NP10679 (Drug)
NP10679 100 mg
NP10679 100 mg intravenous infusion on day 1
干预措施: NP10679 (Drug)
NP10679 200 mg
NP10679 200 mg intravenous infusion on day 1
干预措施: NP10679 (Drug)
NP10679 300 mg
NP10679 300 mg intravenous infusion on day 1
干预措施: NP10679 (Drug)
结局指标
主要结局
Incidence of adverse events as a measure of safety and tolerability
时间窗: 8 days
Observed side effects and alteration in laboratory values.
次要结局
- Plasma concentration of parent drug(4 days)