NCT01405651已完成1 期
A Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-6950 in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of ONO-6950 across ascending multiple doses in healthy adult male and female subjects. The secondary objectives are to characterize the PK and pharmacodynamic (PD) profiles of ONO-6950 by measuring plasma concentrations of ONO-6950 and pulmonary function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Healthy non-smoking male or female subjects (18-55 inclusive)
- •Body mass index (BMI)of 10-35 kg/m2 (inclusive)
- •For females; postmenopausal, non-lactating, and non-pregnant
排除标准
- •History or presence of clinical significant disease
研究组 & 干预措施
E
Experimental
ONO-6950
干预措施: ONO-6950 (Drug)
P
Placebo Comparator
Placebo
干预措施: ONO-6950 (Drug)
结局指标
主要结局
Safety and tolerability of ONO-6950 using vital signs, pulmonary function tests ECGs, laboratory tests and physical examinations
时间窗: At protocol-specified timepoints before and after study drug administration up to 21 days
次要结局
- Characterization of PK ( Cmax, Tmax, AUC, ty2, etc.) and PD profiles of ONO-6950 using plasma concentration of ONO-6950 in blood and pulmonary function tests(At protocol-specified timepoints before and after study drug administration up to 21 days)
研究者
研究点 (1)
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