NCT01847222终止1 期
An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
Prolong Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability.
研究概览
简要总结
Safety assessment of SANGUINATE™ in Healthy Volunteers.
详细描述
Safety and Pharmacokinetic assessment in ascending doses of SANGUINATE™ in Healthy Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male Volunteers;
- •Age ≥18 years and ≤45 years;
- •BMI ≥20- ≤30 kg/m²
- •No clinically significant screening observations
排除标准
- •Female volunteers;
- •Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the results;
- •History of allergy or major allergic reactions considered to be clinically significant by the Investigator;
- •Any screening assessment determined to be clinically significant by the Investigator;
- •Donate blood within 60 days of screening or otherwise experienced blood loss >250 mL within the same period;
研究组 & 干预措施
SANGUINATE™
Experimental
PEG-bHb-CO
干预措施: SANGUINATE™ (Biological)
Normal Saline Solution
Placebo Comparator
Saline Solution
干预措施: Normal Saline Solution (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability.
时间窗: 7 days
Adverse events of SANGUINATE™
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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