A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase 1 clinical trial. This study will determine the safety and side-effect profile of an investigational dexlansoprazole injection after single intravenous administration in healthy Chinese adults.
详细描述
This is a single center, double-blind, dose-escalation, placebo-controlled clinical trial. Dose escalation will be proceeded according to 3+3 design in five predefined dosing groups. After completion of the 90mg dosing study, dose-escalation will be stopped, even though MTD is not be observed. A total of 28 participants is scheduled to be recruited. The whole follow-up period for each participant will be 3 days.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 Years;
- •Male (weight ≥50kg) or female (weight ≥45kg);
- •BMI between 19~28 kg/m2;
- •Healthy subjects (at screening);
- •Subject who totally understand the aim and progress of this clinical trial, make decision by his/her free will, and signed a consent form to follow the progress.
排除标准
- •Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator;
- •Subject who has past or present history of any serious diseases, including (but not limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, psychiatric or neurological, hematologic, immunological or metabolic disorders;
- •Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values;
- •HIV, HBV, or syphilis positive;
- •Drug dependency or abuse;
- •Heavy smokers (>5 cigarettes per day);
- •Alcohol use;
- •Participation in another study with an investigational drug within the last 3 months preceding this study;
- •Blood donation within the last 2 months (>= 400 ml), or have a plan to donate blood within 1 month after this study;
- •Intake of any other drug which might influence the results of the trial during two weeks previous to the start of the study.
研究组 & 干预措施
placebo
干预措施: placebo (Other)
Dexlansoprazole Injection
干预措施: dexlansoprazole injection (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 3 days
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
次要结局
未报告次要终点