Radiation dosimetry and pharmacokinetics of the tau PET tracer florzolotau (18F) in healthy Japanese subjects.

"Declarations Conflict of interestMasaomi Miyamoto and Ming-Kuei Jang are staff and board member of APRINOIA Therapeutics Inc., respectively, and both of whom have stock options in the company. No other potential conflict of interest relevant to this article was reported. Conflict of interest Masaomi Miyamoto and Ming-Kuei Jang are staff and board member of APRINOIA Therapeutics Inc., respectively, and both of whom have stock options in the company. No other potential conflict of interest relevant to this article was reported."

"This study was conducted at the Shiga Medical Center Research Institute in Moriyama, Japan. The clinical study protocol including amendments, informed consent form (ICF), and all other study-related documents were reviewed and approved by an Institutional Review Board of Shiga General Hospital, and the study was conducted in compliance with the study protocol, Good Clinical Practice (GCP) as set forth in the International Conference on Harmonization (ICH) guidelines on GCP (ICH E6(R2)) and registered with the Japan Pharmaceutical Information Center (JapicCTI-205302). The subject inclusion criteria included being male Japanese, age between 20 and 64, the ability to provide his written informed consent, and not diagnosed with any disease affecting participation in the study and being normal at the screening tests of vital signs, electrocardiogram, hematology, and blood biochemical tests. Four subjects were screened, and 3 subjects with height of 175.8 ± 8.7 cm and body weight of 75.7 ± 8.7 kg were enrolled. The fourth subject was enrolled as a spare subject and did not undergo the studies according to the prior arrangement in the study protocol."