NCT01748864已完成1 期
A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers
Endocyte2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2013年4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
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Distribution of Radioactive Drug Substance
研究概览
简要总结
A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in normal volunteers. Study will determine biodistribution and excretion of the radioactive drug substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be 18 years of age or older.
- •Subject must not have any major health problems as deemed by principal investigator.
- •Subject must provide informed consent prior to enrollment.
排除标准
- •Subject is pregnant or breast-feeding.
- •Subject is simultaneously participating in another investigative drug or device study.
- •Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study.
- •Subject has a known history of chronic abuse of drugs or alcohol or tests positive in pre-study urine drug abuse screen.
- •Subject is currently taking folic acid supplements and cannot stop taking the supplements for a period of 8 days (7 days prior to the study and one day after last imaging procedure).
- •Subject's physical condition unsuitable for radionuclide imaging.
- •Subject has been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of 99mTc-etarfolatide.
研究组 & 干预措施
Single Arm - Healthy Volunteers
Experimental
Etarfolatide (EC20)
干预措施: Etarfolatide (EC20) (Drug)
结局指标
主要结局
Distribution of Radioactive Drug Substance
时间窗: 24 hours
To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.
次要结局
- Safety of 99mTc-Etarfolatide in Normal Volunteers(4 days post-injection of EC20)
- Tolerability of 99mTc-Etarfolatide in Normal Volunteers(4 days)
研究者
研究点 (2)
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