臨床研究等提出・公開システム

Date of registration	May. 26, 2020
Last modified on	Nov. 02, 2021
Trial ID	jRCT2080225206

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

Completion Date or Terminated date	Sept. 30, 2021
Actual Enrolled Number	3
Baseline Characteristics	Healthy male subject
Participant flow	Screening was done 14-28 days before the study. PET scans, clinical test, vital signs and ECG were conducted. Next day, adverse event was followed.
Adverse events	Although 6 adverse events were observed at blood chemistry test in one subject, they were mild and recovered. The adverse events were not related to the study drug.
Primary Outcome Measures	The effective dose was calculated as 0.0197 mSv/MBq. Subject will receive and effective dose of approximately 3.61 mSv when 185 MBq [18F]APN-1607 was given to the subject.
Secondary Outcome Measures	No serious adverse event was noted in this study. Evaluation of vital signs and ECG revealed no significant changes.
Brief summary	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.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)	https://www.clinicaltrials.jp/file/wjdnaLUcd
Version of protocol file(s)	version:1.3 date:Oct. 01, 2020

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	APRINOIA Therapeutics Inc.
	Address	Shinkawa 1-2-8, Chuo-ku, Tokyo
	Phone Number	+81-3-6280-4277
	E-mail Address	masaomi.miyamoto@aprinoia.com

Contact for Public Queries	Name
	Contact Name for Public Queries	APRINOIA Therapeutics Inc.
	Address	Shinkawa 1-2-8, Chuo-ku, Tokyo
	Phone Number	+81-3-6280-4277
	E-mail Address	masaomi.miyamoto@aprinoia.com

Recruitment Status	completed

Date of First Enrolment		Dec. 17, 2020
Target Sample Size		3
Study Type		Interventional
Study Design	Study Design	open-label, uncontrolled study
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- 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.
	Exclusion Criteria	- 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.
	Minimum Age	20age old over
	Maximum Age	64age old under
	Gender	Male
Health Condition or Problem Studied		Healthy adult male
Intervention(s)		investigational material(s) Generic name etc : [18F]APN-1607 INN of investigational material : - Therapeutic category code : 43- Radioactive medicines Dosage and Administration for Investigational material : Administer 185 MBq as a single intravenous injection. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Adverse events, laboratory test, vital sign and ECG
Secondary Outcome		pharmacokinetics Radioactivity in whole blood and urine. Absorbed dose in major organs/tissues based on the MIRD method and effective dose.

Primary Sponsor	APRINOIA Therapeutics Inc.
Secondary Sponsor	-

Name of Funding Organization	APRINOIA Therapeutics Inc.
Name of Research Funding	APN-1607-J01 study

Name of IRB	IRB Committee of Shiga General Hospital
Address of IRB	5-4-30 Moriyama, Moriyama-city, Shiga 524-8524
Phone Number of IRB	+81-77-582-5031
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Nov. 09, 2020

Secondary ID No.	JapicCTI-205302
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
2	Nov. 02, 2021	(this page)	Changes
1	May. 27, 2020	Detail

List of change history