Ischemia reperfusion injury
Conditions
Interventions
KSG-001(NO 20ppm, H2 1.3%) single 4 hours inhalation under fasting condition
KSG-001(NO 40ppm, H2 1.3%) single 4 hours inhalation under fasting condition
KSG-001(NO 80ppm, H2 1.3%) single 4 hours i
Sponsors
Kitasato University Kitasato Institute Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
Japan
Contacts
Public ContactTomoko Hasunuma
Kitasato University Kitasato Institute Hospital Department of Research, Clinical Trial Center
Outcome results
None listed