UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older
Title of the study (Brief title)	Hyaluronic acid pharmacokinetics study of ECM-E in 40 years of age or older
Region	Japan

Condition
Condition	Adult
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, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 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, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 8.0 hours later.
Key secondary outcomes	We confirm the safety and the amount of change blood test general, biochemistry, urinalysis. After ECM-E intake, we give test mentioned above 0, 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	Dose comparison
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	2
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
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	40 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	The subjects of the experiment and the Japanese who meet the criteria for all of the following. 1) A person who is Japanese is between 40 and 65 years old at the time of Informed Consent. 2)A person who are blood pressure and body temperature are the following at this clinical trial and the screening. Blood pressure : Systolic 140mmHg less than Diastolic 90mmHg less than Body temperature:35.5-37.0degrees 3)A person who is in the range of more than 15ng/mL and less than 50ng/mL in blood hyaluronic acid concentration. 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 is liver dysfunction is suspected in clinical laboratory values are as follows screening. a) T-Bil 3.0 or more b) GOT, GPT upper limit of normal multiply 2.5 or more (100) c) Al-P upper limit of normal multiply 2.5 or more d) gamma-GTP upper limit of normal multiply 1.5 or more e) LDH upper limit of normal multiply 1.5 or more 2) A person who with the disease to gastrointestinal tract, liver, kidney, the heart which have an influence on absorption, distribution, metabolism, the excretion. 3) 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. 4) A person who has a food allergy in chicken and a chicken egg or a chronic food allergy. 5) A person who has Mucopolysaccharidosis. 6) Person with alcohol or drug dependence. 7) 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. 8) The person who took other drugs for less than one week to start this clinical trial. 9) 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. 10) A person who can not keep the compliance rules of participation in clinical trials and report symptoms. 11) In addition, the person who identified as improper by the principal investigator or subinvestigators. 12) A women who is pregnant or breastfeeding.
Target sample size	16

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 Hayashi
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)

Secondary IDs
Secondary IDs	YES
Study ID_1	JMA-IIA00177
Org. issuing International ID_1	JMACCT Clinical Trials Registry
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	2014 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 27 Day
Anticipated trial start date	2014 Year 04 Month 19 Day
Last follow-up date	2014 Year 05 Month 10 Day
Date of closure to data entry	2014 Year 05 Month 10 Day
Date trial data considered complete	2014 Year 05 Month 30 Day
Date analysis concluded	2014 Year 06 Month 24 Day

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

Management information
Registered date	2014 Year 04 Month 21 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=R000016083