臨床研究等提出・公開システム

Date of registration	Sept. 28, 2026
Last modified on	Sept. 28, 2026
Trial ID	jRCT2071260092

Scientific Title	A phase I study of M875(Multiple Dose Study)
Public Title	A phase I study of M875(Multiple Dose Study)

Contact for Scientific Queries	Name	Fujimoto Souichi
	Affiliation	Medisa Shinyaku Inc.
	Address	5-2-27, Miyahara, Yodogawa-Ku, Osaka-shi, Osaka
	Telephone	+81-6-6150-1105
	E-mail	fujimoto.medisa@sawai.co.jp
Contact for Public Queries	Name	Fujimoto Souichi
	Affiliation	Medisa Shinyaku Inc.
	Address	5-2-27, Miyahara, Yodogawa-Ku, Osaka-shi, Osaka
	Telephone	+81-6-6150-1105
	E-mail	fujimoto.medisa@sawai.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 28, 2026
Target sample size		6
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Japanese healthy adult male aged 18 or older and younger than 45 years at the time of signing informed consent. (2) Persons who weighs between 50 kg and 80 kg. (3)Body mass index(BMI) (Weight (kg)/(Height (m))2)between 18.5 and 25.0 (rounded down to the second decimal place) (4)Persons who are judged by the principal investigator, etc. to be eligible as subjects for this study, taking into consideration the results of the screening test. (5)Persons who are able to undergo the medical examinations and tests specified in the study protocol and report subjective symptoms, etc., in accordance with the compliance requirements during participation in the clinical trial.
	Exclusion Criteria	(1)Persons with gastrointestinal, heart, liver, kidney, blood, or other diseases that may affe ct pharmacokinetics and safety, or with a history of such diseases. (2)Persons with an ALT greater than 45 U/L on the screening test. (3)Persons with WPW syndrome, complete right bundle branch block, or Brugada syndrom e determined by 12-lead ECG in the screening test(including automatic device determin ation). (4)Persons with a history of major surgery in the gastrointestinal tract area, such as gastre ctomy, gastrointestinal suture, or intestinal resection (appendicectomy and inguinal herni a repair are acceptable). (5)Persons with drug hypersensitivity or allergy to drugs. (6)Alcohol or drug dependent persons. (7)Received cephalantin within 12 weeks prior to study drug administration. (8)Persons who participated in another clinical trial and received another investigational dr ug within 12 weeks prior to the administration of the investigational drug (in case of clini cal trials of health food products, this is defined as within 4 weeks prior to the administra tion of the investigational drug). (9)Persons from whom at least 200 mL or 400 mL of blood samples (e.g., blood donation) had been collected within 4 or 12 weeks prior to administration of the investigational dru g, or who had donated blood component within 2 weeks prior to administration of the inv estigational drug. (10)Persons with a confirmed positive immunological test in the screening test. (11)Persons who are judged to be ineligible to participate in the clinical trial by the principal investigator, etc.
	Age Minimum	18age old over
	Age Maximum	45age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy Japanese adult males
Intervention(s)		Multiple Dose Study:Drug administration M875T3 (90 mg) will be administered orally once daily for 10 days within 30 minutes after breakfast with 200 mL of water.
Primary Outcome(s)		Safety Tolerability and Pharmacokinetics

Primary Sponsor	Medisa Shinyaku Inc.

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-Ku, Fukuoka-shi, Fukuoka, Fukuoka
Telephone	+81-92-283-7701
E-Mail	hakataclinic-irb@lta-med.com
Approval Status	Approval
Date of approval	Sept. 17, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none