NCT02291471已完成1 期
An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Maximum Tolerance Dose
研究概览
简要总结
The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers, able to give written informed consent for participation in the trial;
- •Men or women 50% each , aged 18-45 years old;
- •Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time;
排除标准
- •Acute or chronic infection, or history of active tuberculosis;
- •History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
- •Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
- •Subjects with a history of mental problems;
- •Pregnant and lactating women or women who plan to be pregnant in 3 months;
- •Occurence of clinical significant abnormal laboratory examination value during the screening;
- •Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols;
- •Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;
研究组 & 干预措施
T0001
Experimental
干预措施: T0001，10mg (Drug)
T0001
Experimental
干预措施: T0001，20mg (Drug)
T0001
Experimental
干预措施: T0001，35mg (Drug)
T0001
Experimental
干预措施: T0001，50mg (Drug)
T0001
Experimental
干预措施: T0001，65mg (Drug)
T0001
Experimental
干预措施: T0001，75mg (Drug)
结局指标
主要结局
Maximum Tolerance Dose
时间窗: 3 weeks
次要结局
- Adverse events(3 weeks)
- pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc）(Pre-dose，2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection)
研究者
研究点 (1)
Loading locations...
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