UMIN-CTR Clinical Trial

Basic information
Public title	Safety observation study for healthy individuals of intravenous administration of NMN.
Acronym	Safety assessment of NMN infusion therapy.
Scientific Title	Safety observation study for healthy individuals of intravenous administration of NMN.
Scientific Title:Acronym	Safety assessment of NMN infusion therapy.
Region	Japan

Condition
Condition	healthy individuals
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the safety of a single dose of NMN in healthy individuals and to assess blood NAD levels and SIRT1 activation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of intravenous administration of NMN (clinical parameters).
Key secondary outcomes	Analysis of NAD+ levels and SIRT1 activation in blood.

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	Treatment
Type of intervention	Other
Interventions/Control_1	Single intravenous administration of NMN.
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	The healthy subjects who agree to the study.
Key exclusion criteria	1. The subjects with a previous history of diseases. 2. The subjects with malignant neoplasms. 3. The subjects with serious infections. 4. The subjects with psychiatric disorders. 5. The subjects with ophthalmic disorder. 6. The subjects with allergic disorders. 7. The subjects who are regarded as inadequate by the investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Akinobu Middle name Last name Gotoh
Organization	Hyogo College of Medicine
Division name	Department of Education for Medical Research Base
Zip code	6638501
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL	0798-45-6807
Email	gotoh@hyo-med.ac.jp

Public contact
Name of contact person	1st name Shintarou Middle name Last name Kimura
Organization	StateArt Inc.
Division name	Research and Development Department
Zip code	1030012
Address	2-9-12 Horidome-cho, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL	03-5859-5193
Homepage URL
Email	s.kimura@stateart.co.jp

Sponsor
Institute	StateArt Inc.
Institute
Department

Funding Source
Organization	StateArt Inc.
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	Japanese Organization for Safety Assessment of Clinical Research
Address	13-16 Sanjominami-cho, Ashiya, Hyogo, Japan
Tel	0797-22-5511
Email	info@sacrj.com

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	2022 Year 03 Month 09 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	10
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	2021 Year 05 Month 31 Day
Date of IRB	2021 Year 06 Month 23 Day
Anticipated trial start date	2021 Year 06 Month 23 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 09 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053763