PC-SOD NE (PhaseIIa) -Repeated Dose Study in IPF patients
- Conditions
- idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000009573
- Lead Sponsor
- TT Bio Pharma Co., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 4
Not provided
(1)Exclusion criteria involving similar diseases 1.Patients who's IPF was clearly caused by pharmaceuticals 2.Patients diagnosed with COPD or asthma or airway infection (2)Exclusion criteria due to previous treatment (3)Patients who are moderate intake of alcohol or alcoholics (4)Patients of chemical dependency (5)Patients who are smokers within a month(6)Patients are sensitive to any drugs (alldrugs prescribed or commercially available drugs) or have history of sensitivity to the drugs (7)Before 4 wee (8)Patients who participated in another clinical study within 4 months prior to the administration period of the study drug (9)Patients who are pregnant or possibly pregnant, or nursing (10)Patients who have taken PC-SOD previously in their medical history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1)Safety Adverse event subjective, objective weight vital signs 12-lead electrocardiogram lung function test Clinical test antibody titer in blood of PC-SOD (2)Pharmacological effect Biomarker(LDH, SP-A, SP-D, KL-6) (3)Pharmacokinetics blood serum concentration of PC-SOD
- Secondary Outcome Measures
Name Time Method