臨床研究等提出・公開システム

Date of registration	Mar. 14, 2025
Last modified on	Dec. 19, 2025
Trial ID	jRCT2071240129

Scientific Title	A Phase I, randomized, double-blind, placebo-controlled, comparative study to evaluate the safety, tolerability, and pharmacokinetics of repeated doses of TKT001-S in healthy Japanese adult males.
Public Title	Phase I Repeated Dose Study of TKT001-S

Contact for Scientific Queries	Name	Kai Megumi
	Affiliation	Oita University Hospital
	Address	1-1 Idaigaoka Hasama-machi Yufu Oita 879-5593
	Telephone	+81-97-549-4411
	E-mail	mashimo@serenpharma.com
Contact for Public Queries	Name	Mashimo Shigeto
	Affiliation	Seren Pharmaceuticals Inc.
	Address	1-2-13, Nihonbashi Ningyocho, Chuo-ku, Tokyo
	Telephone	+81-3-5244-9343
	E-mail	mashimo@serenpharma.com

Recruitment status	Complete

Anticipated date of first enrollment		May. 12, 2025
Actual date of first enrollment		May. 12, 2025
Target sample size		24
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	Japanese healthy males between the age of 20 to under 45 years Those who the BMI between 18.5 kg/m^2to under 28.0 kg/m^2
	Exclusion Criteria	Those with illnesses that may affect the evaluation of the drug History of hepatic, renal, or gastrointestinal or radiotherapy treatment that affects drug absorption Those with a history or suspected history of alcohol or drug abuse
	Age Minimum	20age 0month 0week old over
	Age Maximum	45age 0month 0week old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy adult males
Intervention(s)		Repeated doses of TKT001-S or TKT001-S placebo
Primary Outcome(s)		Phamacokinetics,Safety,Tolerability

Primary Sponsor	Seren Pharmaceuticals Inc.

Secondary Sponsor

Name of Certified Review Board	Oita University Hospital Institutional Review Board
Address	1-1 Idaigaoka Hasama-machi Yufu Oita 879-5593, Oita
Telephone	+81-97-586-6163
E-Mail	gcrcjimu@oita-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 13, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 19, 2025	(this page)	Changes
3	May. 20, 2025	Detail	Changes
2	April. 17, 2025	Detail	Changes
1	Mar. 14, 2025	Detail

List of change history