A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of PMK-S005 After Oral Administration in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The Purpose of a randomized, double-blind, placebo-controlled, single-dose, dose-escalation clinical trial is to explore investigate the safety, tolerability, pharmacokinetics, and food effect of PMK-S005 after oral administration in healthy male volunteers.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male 20 year ≤ age ≤ 40 year.
- •Weight ≥ 55kg, IBW ±20%.
- •Patients with normal hematology, biochemistry, urinary result.
- •Patients who have not congenital or chronic disease.
- •Provision of written informed consent voluntarily.
排除标准
- •Patients having known hypersensitivity to any component of the study drug.
- •Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.
- •Patients with any gastrointestinal disorders.
- •Systolic blood pressure ≥ 150 or ≤ 90 mmHg, Diasolic blood pressure ≥ 95 or ≤ 50 mmHg.
- •Drug abuser, alcoholic.
- •Patients taking ETC medication within 14 days, OTC within 7 days.
- •Patients taking other investigational product within 60 days prior to the participation in the study.
研究组 & 干预措施
PMK-S005
干预措施: PMK-S005 (Drug)
结局指标
主要结局
Safety
时间窗: 8day
1. Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. 2. Before and after physical examination 3. Before and after bital Sign: blood pressure, pulse rate, temperature. 4. Before and after 12-ECG: ventricular rate (/min), PR interval (msec), QRS duration (msec), QT/QTc interval (msec. 5. Lab: hematologic examination, blood coagulation examination,urine examination
Pharmacokinetics
时间窗: 8day
1. Blood evaluation variables: Cmax, AUCt (t=48 h), AUC∞, tmax, CL/F, t1/2. 2. Urine evaluation variables: Aet (t=48 h), Ae∞, urine recovery
次要结局
未报告次要终点