UMIN-CTR Clinical Trial

Basic information
Public title	Safety evaluation
Acronym	Safety evaluation
Scientific Title	Safety evaluation of excessive intake of ONO-SR/AST-SOYPC for healthy adults.
Scientific Title:Acronym	Safety evaluation of excessive intake of ONO-SR/AST-SOYPC
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of ONO-SR/AST-SOYPC daily intake, for 4 weeks
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of ONO-SR/AST-SOYPC 5-fold quantity of recommended daily intake, for 4 weeks
Interventions/Control_2
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	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy males and females from 20 to 64 years of age
Key exclusion criteria	(1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (3) Subjects having possibilities for emerging allergy related to the study (4) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (5) Subjects having a drug dependence, alcohol dependence requiring treatment or a history of serious alcohol dependence (6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yasunari Middle name Last name Noda
Organization	ONO PHARMACEUTICAL CO., LTD.
Division name	Business Design Department
Zip code	541-8564
Address	8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka
TEL	06-6263-2924
Email	ya.noda@ono.co.jp

Public contact
Name of contact person	1st name Mariko Middle name Last name Kondo
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	m.kondo@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Ono Pharmaceutical co., ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 08 Month 06 Day
Date of IRB	2020 Year 08 Month 06 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 11 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 24 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047413