臨床研究等提出・公開システム

Date of registration	Jan. 28, 2025
Last modified on	Sept. 17, 2025
Trial ID	jRCT2051240252

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

Contact for Scientific Queries	Name	Osamu Matsuoka
	Affiliation	Medical Corporation Heishinkai ToCROM Clinic
	Address	4-9 Yotsuya-Saneicho, Shinjuku-ku, Tokyo 160-0008 JAPAN
	Telephone	+81-466-27-3205
	E-mail	info@scohia.com
Contact for Public Queries	Name	Business Development and Corporate Operation
	Affiliation	SCOHIA PHARMA, Inc.
	Address	26-1, Muraoka Higashi 2-chome Fujisawa, Kanagawa
	Telephone	+81-466-27-3205
	E-mail	info@scohia.com

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 28, 2025
Target sample size		32
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 - Age: Subjects are between 18 and 65 years, inclusive, at the time of informed consent - Weight at screening: >=50 kg, body mass index (BMI) >=18.5 kg/m2 and =<25.0 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	18age old over
	Age Maximum	65age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Short statue caused by growth hormone deficiency
Intervention(s)		Once daily, 7days repeated dose of SCO-240 3mg, 10mg, 20mg, 80mg or placebo with fasted condition
Primary Outcome(s)		Safety and pharmacokinetics
Secondary Outcome(s)		Pharamacodynamics

Primary Sponsor	SCOHIA PHARMA, Inc.

Source of Monetary Support	Japan Agency for Medical Research and Development (AMED)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29 Miyahara,Yodogawa-ku,Osaka-shi,Osaka 532-0003 JAPAN, Osaka
Telephone	+81-6-6395-9000
E-Mail	ophach_irb@heishinkai.com
Approval Status	Approval
Date of approval	Jan. 16, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Sept. 17, 2025	(this page)	Changes
1	Jan. 28, 2025	Detail

List of change history