臨床研究等提出・公開システム

Date of registration	Jan. 10, 2018
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223770

Scientific Title	A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Dose of SCO-792 in the Healthy Adult Subjects.
Public Title	Multiple-Dose Phase 1 Study of SCO-792

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	SCOHIA PHARMA, Inc.
	Address	https://www.scohia.com/eng/
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	SCOHIA PHARMA, Inc.
	Address	https://www.scohia.com/eng/
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		36
Study Type		Interventional
Study Design	Study Design	Randomized, Double-Blind, Placebo-Controlled Study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	# The participant is aged 20 to 45 years, inclusive, at the time of informed consent. # The participant weights at least 50 kg and has a body mass index between 18.5 and 25.0 kg/m2 for Japanese.
	Exclusion Criteria	# The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of randomized study drug. # The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
	Minimum Age	20age old over
	Maximum Age	45age old under
	Gender	Male
Health Condition or Problem Studied		Healthy Adult Male Participants
Intervention(s)		investigational material(s) Generic name etc : SCO-792 INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : SCO-792 250 mg, 500 mg, or 750 mg will be administered before every meal. control material(s) Generic name etc : SCO-792 Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : SCO-792 placebo will be administered before every meal.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Number of participants who experience at least 1 treatment-emergent adverse event An adverse event is defined as any untoward or unintended sign, symptom, or illness that occurs with administration of a study drug regardless of whether it is causally related to the study drug.
Secondary Outcome		AUC(0-tlqc), Tmax, Cmax for SCO-792 AUC(0-tlqc): Area under the plasma concentration-time curve from Time 0 to Time of the Last Quantifiable Concentration Tmax: Time to reach the maximum plasma concentration Cmax: Maximum observed plasma concentration

Primary Sponsor	SCOHIA PHARMA, Inc.
Secondary Sponsor

Name of Funding Organization	SCOHIA PHARMA, Inc.
Name of Research Funding

Name of Funding Organization
Name of Research Funding	SCOHIA R&D expenses

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-183826
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Aug. 01, 2018	Detail	Changes
3	Aug. 01, 2018	Detail	Changes
2	Jan. 10, 2018	Detail	Changes
1	Jan. 10, 2018	Detail

List of change history