臨床研究等提出・公開システム

Date of registration	Jan. 22, 2023
Last modified on	April. 01, 2026
Trial ID	jRCT2031220579

Scientific Title	A Phase 1 Study of Apraglutide (Single Dose Study)
Public Title	A Phase 1 Study of Apraglutide (Single Dose Study)

Contact for Scientific Queries	Name	Kozaki Tomohito
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp
Contact for Public Queries	Name	Contact for Clinical Trial Information
	Affiliation	ASAHI KASEI THERAPEUTICS CORPORATION
	Address	1-1-2 Yurakucho, Chiyoda-ku, Tokyo
	Telephone	+81-3-6699-3600
	E-mail	ct-info@om.asahi-kasei.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 23, 2023
Actual date of first enrollment		Mar. 11, 2023
Target sample size		36
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	The subjects will be individuals who meet all of the following criteria. [1] Healthy Japanese men and women [2] Individuals >=18 to <45 years of age at the time of informed consent [3] Individuals who fully understand the details of the study and who are capable of providing written informed consent
	Exclusion Criteria	Individuals meeting any of the following criteria will be excluded from the study. [1] Past history of disease in organsystems considered unsuitable for this study [2] Past history of disease or surgery that could affect pharmacokinetic or pharmacodynamic evaluation [3] Other protocol defined exclusion criteria could apply
	Age Minimum	18age old over
	Age Maximum	45age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		short bowel syndrome and intestinal failure (SBS-IF)
Intervention(s)		Apraglutide (TA799) 2.5mg, 5mg, 10mg subcutaneously single administration and blood collection
Primary Outcome(s)		Plasma concentration of compound(s)

Primary Sponsor	ASAHI KASEI THERAPEUTICS CORPORATION

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-5213-0028
E-Mail	secretariat@hurecs.org
Approval Status	Approval
Date of approval	Feb. 17, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	April. 01, 2026	(this page)	Changes
5	Aug. 09, 2023	Detail	Changes
4	June. 24, 2023	Detail	Changes
3	Mar. 31, 2023	Detail	Changes
2	Mar. 03, 2023	Detail	Changes
1	Jan. 22, 2023	Detail

List of change history