PC-SOD NE (Phase I) -Repeated Dose Study in healthy volunteers
- Conditions
- idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000008921
- Lead Sponsor
- TT Bio Pharma Co., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 8
Not provided
(1)BMI:<18.5 or >=25.0 (2)Exclusion criteria due to previous Cardiovascular system, blood systems, neuropsychiatric disorder, liver, kidney, respiratory system, endocrine system, alimentary system and a malignant tumor (3)Patients who are moderate intake of alcoholics, Patients of chemical dependency (4)Patients who are regular smokers (5)Patients of sensitive to any drug within 4 weeks. (6)Patients who took a prescribed drug within 4 weeks (7)Patients who obtained a blood sample of 200mL within 4 weeks or exceed 400mL within 12 weeks prior to the administration period of the study drug. (8)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug. (9)Patients determined for other reasons not to be suitable to enter the current clinical study safety by PI or subinvestigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1)Safety Adverse event subjective, objective body temperature blood pressure, pulse rate 12-lead electrocardiogram Clinical test (2)Pharmacokinetics blood serum concentration of PC-SOD
- Secondary Outcome Measures
Name Time Method