NCT04327765已完成1 期
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
研究概览
简要总结
To examine the tolerability and safety of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers To characterize the pharmacokinetics of AZ-010 following 7 days of dosing (up to 3 mg) in healthy volunteers
详细描述
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of Staccato Granisetron (AZ-010) in Healthy Volunteers
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy based on a medical evaluation including history, physical examination, vital signs, electrocardiograms (ECGs) and laboratory tests assessed at the screening visit and prior to the first dose of study drug.
- •Body weight ≥ 50 kg and BMI within the range of 18 to 32 kg/m2, inclusive, at screening.
- •Negative urine tests for selected drugs of abuse and alcohol breath test at screening and Day 1.
排除标准
- •Any significant medical condition
研究组 & 干预措施
Cohort 1
Experimental
Single orally-inhaled dose
干预措施: 0.5mg AZ-010 (Combination Product)
Cohort 2
Experimental
Single orally-inhaled dose
干预措施: 1mg AZ-010 (Combination Product)
Cohort 3
Experimental
Single orally-inhaled dose
干预措施: 3mg AZ-010 (Combination Product)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
时间窗: 8 days
Number of Subjects with Adverse Events as a measure of Safety and Tolerability
次要结局
- Measurement of Granisetron Exposure in Plasma(8 days)
- Measurement of Granisetron Time to Maximum Exposure in Plasma(8 days)
- Measurement of Granisetron Maximum exposure in Plasma(8 days)
研究者
研究点 (1)
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