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临床试验/jRCT2080225206
jRCT2080225206已完成1 期

A phase 1 study of a novel tau PET imaging agent [18F]APN-1607

APRINOIA Therapeutics Inc.1 个研究点目标入组 3 人开始时间: 待定最近更新:
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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A phase 1 study of [18F]APN-1607 | 临床试验