UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031061 |
|---|---|
| Receipt number | R000035470 |
| Scientific Title | Safety and Tolerability study of KSG-001 (NO-H2 gas) in healthy Japanese males |
| Date of disclosure of the study information | 2018/01/30 |
| Last modified on | 2018/04/02 10:43:28 |
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Basic information
Public title
Safety and Tolerability study of KSG-001 (NO-H2 gas) in healthy Japanese males
Acronym
Safety and Tolerability study of KSG-001 (NO-H2 gas) in healthy Japanese males
Scientific Title
Safety and Tolerability study of KSG-001 (NO-H2 gas) in healthy Japanese males
Scientific Title:Acronym
Safety and Tolerability study of KSG-001 (NO-H2 gas) in healthy Japanese males
Region
| Japan |
Condition
Condition
Ischemia reperfusion injury
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and tolerability of KSG-001 continuous inhalation in healthy Japanese males
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
KSG-001(NO 20ppm, H2 1.3%)
single 4 hours inhalation under fasting condition
Interventions/Control_2
KSG-001(NO 40ppm, H2 1.3%)
single 4 hours inhalation under fasting condition
Interventions/Control_3
KSG-001(NO 80ppm, H2 1.3%)
single 4 hours inhalation under fasting condition
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
1) Japanese healthy male volunteer
2) Age between 20 and 40 at gave written informed consent
3) Body mass index between 18.5 and 25.0
4) Judged eligibility by investigator within 24hrs of investigational product (IP) inhalation
5) Negative for HBs Ag, HCV Ab, HIV Ag, HIV Ab, and syphilis test
6) Non-smoker at informed consent (no-smoking within 6 months and no-longer than one month in total life)
7) No present or past history of drug and alcohol abuse
8) Able to follow the protocol, undergo concultation/examination as described in the protocol and report their symptoms
9) Gave written informed consent upon participation in the study
10) Underwent screening tests within one month before investigational product administration and judged eligibility by investigator
Key exclusion criteria
1) Have a medical history or complication such as liver, renal, cardiovascular, and digestive system disorders which is considered to unfit for the study
2) Have a medical history of cancer, cerebral infarction, and myocardial ischemia
3) Have a medical history or complication which affect respiratory system significantly
4) Have a history of surgical operation on digestive, respiratory or renal system, except operation which does not affect drug inhalation (appendectomy, hemorrhoid, pneumothorax, etc)
5) Have a history of epilepsy, or possibility of epilepsy caused by brain disorder
6) Have a history or complication of allergy or specific constitution to food, drug, and metal
7) More than 1% of methemoglobin at screening
8) Less than 94% of SpO2 at screening
9) More than 450 ms of QTcF in EKG at screening
10) Donated whole blood more than 400 mL or blood component more than 200mL within 12 weeks before IP inhalation
11) Ingested any medicine or OTC, supplement (ex. Saint jones worth, etc) within 1 week before IP inhalation except topical drugs which is not for therapeutic use such as eye drops to prevent dryness / discomfort at contact lens and topical disinfectant to prevent infection
12) Ingested any food or drink containing alcohol or caffeine
13) Ingested another clinical study drug within 16 weeks before IP inhalation
14) Participated in another clinical study or research within 16 weeks before IP inhalation
15) Exercised excessibly within 3 days before IP inhalation
16) Unable to agree with contraception after IP inhalation
17) Considered unfit for the study by investigator
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Hasunuma |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Department of Research, Clinical Trial Center
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo 108-8642
TEL
+81-3-5791-6350
t-hasu@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Hasunuma |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Department of Research, Clinical Trial Center
Zip code
Address
5-9-1 Shirokane, Minato-ku, Tokyo 108-8642
TEL
+81-3-5791-6350
Homepage URL
t-hasu@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 30 | 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
| 2018 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2018 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035470
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