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

APRINOIA Therapeutics Inc.0 个研究点目标入组 3 人开始时间: 2020年5月26日最近更新: 2023年10月17日

适应症

试验速览

APN-1607 injection was well tolerated in healthy subjects. The effective dose was 3.61 mSv when 185 MBq [18F]APN-1607 was given to the subject.

•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.

•- 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.

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