UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047134 |
|---|---|
| Receipt number | R000053763 |
| Scientific Title | Safety observation study for healthy individuals of intravenous administration of NMN. |
| Date of disclosure of the study information | 2022/03/09 |
| Last modified on | 2022/03/14 16:37:49 |
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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
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
s.kimura@stateart.co.jp
Sponsor or person
Institute
StateArt Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053763
