UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hyaluronic acid pharmacokinetics study of ECM-E
Title of the study (Brief title)	Hyaluronic acid pharmacokinetics study of ECM-E
Region	Japan

Condition
Condition	Healthy male subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We confirm blood kinetics of the hyaluronic acid after the ECM-E (hyaluronic acid made from a cockscomb) intake. After ECM-E intake, a blood level of the hyaluronic acid is measured in 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0 hours later.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	We confirm blood kinetics of the hyaluronic acid after the ECM-E (hyaluronic acid made from a cockscomb) intake. After ECM-E intake, a blood level of the hyaluronic acid is measured in 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0 hours later.
Key secondary outcomes	We confirm safety by a general blood test, a biochemical test, urinalysis. After ECM-E intake, we give test mentioned above 0, 4, 8 hours later.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Medicine Food
Interventions/Control_1	ECM-E Intake:3000mg Ingestion period:1day
Interventions/Control_2	ECM-E Intake:1200mg Ingestion period:1day
Interventions/Control_3	Placebo Intake:3000mg Ingestion period:1day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	The subjects for the experiment must be healthy male subjects who meets all the following standards. 1) A person who is Japanese male and is between 20 and 40 years old at the time of Informed Consent. 2) A person who is in the range of more than 18.5 and less than 25 in BMI(standard value (22)), based on the diagnostic criteria of the Japan Society for the Study of Obesity at this clinical trial and the screening. BMI(Body Mass Index) = Weight(kg) / (Height(m))2 3) A person whose blood pressure, pulse and body temperature are the following at this clinical trial and the screening. Blood pressure : Systolic 130mmHg less than Diastolic 85mmHg less than Pulse:50-100 time/minute Body temperature:35.5-37.0degrees 4) A person who received a full explanation about the expected objectives of the test food and the clinical test and the side effects at the screening from clinical research investigator (or subinvestigators), and agreed on the application with written informed consent for this clinical trial spontaneously upon well understanding. 5) The person who can discontinue smoking on the clinical trials day 6) A person who can comply with the management issues in the implementation medical institutions. 7) The person who was qualified by principal investigator or sub investigator in the screening test within 60 days of this clinical trials implementation.
Key exclusion criteria	The subjects in conflict with any of the following condition are excluded. 1) A person who with the disease to gastrointestinal tract, liver, kidney, the heart which have an influence on absorption, distribution, metabolism, the excretion. 2) A person with a history of the surgery considerable in the gastrointestinal tract site, for example, gastrectomy, stomach and intestines suturation, intestinal tract resection and so on. 3) A person who has a food allergy in chicken and a chicken egg or a chronic food allergy. 4) A person who has Mucopolysaccharidosis. 5) Person with alcohol or drug dependence. 6) A person who has participated in other clinical study or received medical treatment of new drug within 3 months at the time of obtaining informed consent. 7) The person who took other drugs for less than one week to start this clinical trial. 8) A person who has taken the whole blood bleeds or apheresis(plasma apheresis and platelet apheresis) more than 200mL within 3 months at the time of obtaining informed consent or during the period between the time of obtaining informed consent and this clinical trial implementation. 9) A person who can not keep the compliance rules of participation in clinical trials and report symptoms. 10) In addition, the person who identified as improper by the principal investigator or subinvestigators.
Target sample size	15

Research contact person
Name of lead principal investigator	Shigehiro Kure
Organization	Sanbongi Clinic
Division name	Clinic Director
Address	2-1, Hosohazama, Sambongi-cho, Nisshin-shi, Aichi, 470-0101, Japan
TEL	0561-56-4532
Email	shigehiro_kure@yahoo.co.jp

Public contact
Name of contact person	Hiromichi Hiromichi
Organization	Medical Fusion Co.,Ltd.
Division name	Clinical Development Division
Address	Nagoya Life Science Incubator, 2-22-8, Chikusa, Chikusa-ku, Nagoya, Aichi, 464-0858, Japan
TEL	052-745-3300
Homepage URL
Email	info@m-fusion.co.jp

Sponsor
Institute	ADAPTGEN PHARMACEUTICAL CO.,LTD.
Institute
Department

Funding Source
Organization	ADAPTGEN PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	1,Medical institutions conduct clinical research MEDOC Medical Dock&Clinic 2,CRO Medical Fusion Co.,Ltd.
Name of secondary funｄer(s)	Shachihata Inc,. Provision of "PC approval"management software and electronic seal

Secondary IDs
Secondary IDs	YES
Study ID_1	JMA-IIA00141
Org. issuing International ID_1	JMACCT CTR
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人メドック健康クリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 15 Day
Anticipated trial start date	2013 Year 09 Month 14 Day
Last follow-up date	2013 Year 10 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 11 Day
Last modified on	2017 Year 09 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013700