A Multicenter, single blind, dose-escalation, Investigator initiated trial for single intravenous administration of NK-104-NP to male adult Healthy volunteers
- Conditions
- Pulmonary Hypertension
- Registration Number
- JPRN-UMIN000014940
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 40
Not provided
1)A person who has history of drug allergy. 2)A person who has hypersensitivity including allergy (except asymptomatic allergy). 3)A person who used other therapeutic drugs within 2 weeks or who needs other therapeutic drugs during the clinical trial participation period. 4)A person who used other OTC drugs within a week or who needs other OTC drugs during the clinical trial participation period. 5)A person who donated over 200 mL of whole blood within a month, who experienced plasmapheresis/platelet apheresis within 2 weeks or who donated over 400 mL of whole blood within 3 months. 6)A person who was entolled and given new drugs in other clinical trials within four months before this clinical trial or a person who participates in other clinical trials at the same time with this clinical trial. 7)A person whose percutaneous arterial oxygen saturation is less than 95%. 8)A person with alcohol or drug dependency. 9)A person who is positive for drug abuse tests. 10)A person who is positive for the following tests: HBs antigen, HCV antibody, HIV antigen/antibody or syphilis serum reaction. 11)A person who cannot prevent pregnancy during 6 months after this clinical trial. 12)A person assessed as ineligible for enrollment by investigators of this clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ames, severity and incidence rate of adverse effect and adverse drug reactions.
- Secondary Outcome Measures
Name Time Method