JPRN-jRCT1080224924已完成1 期
An ascending single dose, randomised, double-blind, placebo-controlled phase 1 study of the tolerability, pharmacokinetics and pharmacodynamics of AJM300 in healthy adult males in the fasting and fed states
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 54age old（—）
- 性别
- Male
入选标准
- •Main inclusion criteria
- •- Able to provide written informed consent.
- •- Male subjects aged>=18 to < 55 years and in good health as determined at screening.
- •- BMI within 18-28 kg/m2.
- •- Able to communicate well with the Investigator and comply with the study requirements.
排除标准
- •Main exclusion criteria
- •- Any medical or surgical condition which might significantly alter drug absorption,distribution metabolism of excretion.
- •- Concurrent gastrointestinal disease.
- •- History of drug allergy.
- •- History of drug or alcohol abuse.
- •- Current smokers or cessation of smoking within 3 months of dosing.
- •- Use of any prescription medication within 28 days prior to dosing and over-the counter medication and vitamins within 3 days prior to dosing.
- •- Participation in any clinical study within 3 months prior to dosing.
研究者
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