NCT01223924已完成1 期
Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Protgen Ltd
- 入组人数
- 33
- 主要终点
- To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability
研究概览
简要总结
This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.
详细描述
Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.
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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physical and mental healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening.
- •19 to 45 years of age.
- •Body mass index (19-25 kg/m2) ,the body weight ≥55kg for male subject,≥45kg for female.
- •Negative pregnant test, no menstrual period for female.
- •willing to comply with the protocol.
排除标准
- •Be allergic to endostatin
- •Have taken any drug during the last 2 weeks
- •Have Participated any clinical trail during the last 2 week
- •Cardiovasculre, respiratory, Liver, renal, gastro-intestinal hematologic endocrine and mental disease
- •HIV-1 infected
- •HBV, HBV infected ,Hepatitis B surface antigen positive
研究组 & 干预措施
M2ES 7.5-90mg
Experimental
M2ES dose escalating
干预措施: M2ES (Drug)
Placebo
Placebo Comparator
placebo contract
干预措施: placebo (Other)
结局指标
主要结局
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability
时间窗: 3 weeks
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Subjects With Advanced Solid Tumors
次要结局
- Pharmacokinetic (PK) behavior(3 weeks)
研究者
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