NCT01481597已完成1 期
Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy 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
- 32
- 试验地点
- 1
- 主要终点
- number of participants with adverse events
研究概览
简要总结
Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Chinese healthy male and/or female subjects
- •18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2
- •weigh at least 45 kg for female subjects or 50 kg for male subjects
- •In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
排除标准
- •Significant illness or major surgery within four weeks prior to dosing
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy)
- •Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing
- •Participation in any clinical investigation within 30 days prior to dosing
- •Smokers, alcoholics, drug abusers
- •Immunodeficiency diseases, including a positive HIV test result, Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- •pregnancy or lactation for female subjects
研究组 & 干预措施
deuteporfin 1mg/kg
Experimental
干预措施: deuteporfin (Drug)
deuteporfin 2.5mg/kg
Active Comparator
干预措施: deuteporfin (Drug)
deuteporfin 5mg/kg
Active Comparator
干预措施: deuteporfin (Drug)
deuteporfin 7.5mg/kg
Active Comparator
干预措施: deuteporfin (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
number of participants with adverse events
时间窗: up to 19 days following injection
number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects
次要结局
- Pharmacokinetic profile(predose, 20, 40 and 60 min during-dose, and 5, 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8 ,12, 24h post-dose)
研究者
研究点 (1)
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