臨床研究等提出・公開システム

Date of registration	May. 19, 2021
Last modified on	May. 19, 2021
Trial ID	jRCT2051210027

Scientific Title	A Randomized, Single-Center, Double-Blind, Placebo-Controlled, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SCO-240 in Healthy Adult Subjects
Public Title	Phase I SCO-240 single dose study

Contact for Scientific Queries	Name	Araki Takahiro
	Affiliation	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa
	Telephone	+81-466-32-1592
	E-mail	info@scohia.com
Contact for Public Queries	Name	Clinical Development Division
	Affiliation	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa
	Telephone	+81-466-322-1592
	E-mail	info@scohia.com

Recruitment status	Pending

Anticipated date of first enrollment		May. 23, 2021
Target sample size		76
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	- Gender: Male - Race: Healthy Japanese adults: The subject's parents and grand parents are Japanese Healthy Caucasian adults: The subject's parents and grandparents are Caucasian - Age: Subjects are between 20 and 45 years, inclusive, at the time of informed consent - Weight at screening: Healthy Japanese adults: >=50 kg, body mass index (BMI) >=18.5 kg/m2 and =<25.0 kg/m2 Healthy Caucasian adults >=50 kg, BMI >=18.5 kg/m2 and =<30.0 kg/m2
	Exclusion Criteria	- Subjects who have a present illness such as cardiovascular disease, central nervous system disease, gastrointestinal disease, hematopoietic disease, renal failure, metabolic or endocrine disorder, serious allergy, asthma, hypoxemia, hypertension, convulsion or allergic rash.
	Age Minimum	20age old over
	Age Maximum	45age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Cholelithiasis
Intervention(s)		[Dose Ascending Part] Single oral dose of SCO-240 1mg, 3mg, 20mg, 40mg, 80mg, 160mg or placebo with fasted condition [Racial Difference Effect Part] Single oral dose of SCO-240 20mg or placebo with fasted condition [Food Effect Part] Single oral dose of SCO-240 20mg before or after the breakfast
Primary Outcome(s)		-Safety, pharmacokinetics and pharmacodynamics

Primary Sponsor	SCOHIA PHARMA, Inc.

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Telephone	+81-6-6395-9000
Approval Status	Approval
Date of approval	May. 06, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none