A Randomized, Double-blinded, Placebo-controlled, Single Center, Dose Escalation, Phase I Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
研究概览
简要总结
To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged between 20 and 65 years
排除标准
- •Subject not appropriate for participating in this study according to the investigator's opinion
研究组 & 干预措施
MT921 60mg Group
MT921 60 mg
干预措施: MT921 (Drug)
MT921 120mg Group
MT921 120 mg
干预措施: MT921 (Drug)
MT921 150mg Group
MT921 150 mg
干预措施: MT921 (Drug)
Placebo Group
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
时间窗: Up to 24 hours
Peak plasma concentration measured by Liquid Chromatography-mass spectrometry (LC/MS) achieving in the test area of the body after administration.
AUC0-24
时间窗: Up to 24 hours
Area under the plasma concentration versus time curve from time 0 to 24 hours measured by Liquid Chromatography-mass spectrometry (LC/MS) after administration
Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
时间窗: Up to 24 hours
The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS).
Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS)
时间窗: Up to 24 hours
The time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50% measured by Liquid Chromatography-mass spectrometry (LC/MS).
次要结局
未报告次要终点