jRCT2080225206已完成1 期
A phase 1 study of a novel tau PET imaging agent [18F]APN-1607
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open-label, Uncontrolled Study
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 64age old under(—)
- 性别
- Male
入选标准
- •The subject is capable of understanding this clinical study and providing written consent to participate in this study.
- •The subject is free of any disease potentially affecting his participation or assessments in the study on the basis of the examination at screening.
- •The subject makes sure to use birth control for one week after study drug administration.
排除标准
- •The subject has a clinically significant abnormal value in the laboratory test at screening.
- •The subject has known hypersensitivity to any ingredient of the study drug.
- •The subject is intolerant of prolonged restraint on a bed of a PET scanner.
- •The subject with poor venous access.
- •The subject has history of evisceration that can interferes with calculation of absorbed dose.
- •The subject received or plans to receive a barium swallow test within 2 weeks prior to study drug administration.
- •The subject has received nuclear medicine test and exposed to radiation over 20 mSv within one year prior to study drug administration.
- •The subject participated in the other interventional clinical study or research within three months prior to study drug administration.
- •The subject, in the opinion of the investigator or co-investigator, is ineligible for participation in this study for any other reason.
结局指标
主要结局
-
safety Adverse events, laboratory test, vital sign and ECG
次要结局
- Radioactivity in whole blood and urine
- Absorbed dose in major organs/tissues
- Effective dose
研究者
研究点 (1)
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