idiopathic pulmonary fibrosis
Conditions
Interventions
PC-SOD was inhaled at single doses of 5mg, 20mg and 40mg.
Placebo was inhaled at single doses of 5mg, 20mg and 40mg.
Sponsors
LTT Bio Pharma Co., LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1)Sex: Male (2)Age:20-50 years (3)Japanese (4)All patients must provide written informed consent (5)Patients who the principal investigator or the investigator judges medically suitable for inclusion in the clinical investigation based on examination at screening conduceted within 28days prior to study drug administration
Exclusion criteria
Exclusion criteria: (1)BMI:<18.5 or >=25.0 (2)Exclusion criteria due to previous A 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 drugs (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 4months 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1)Safety Adverse event Subjective, objective weight vital signs 12-lead electrocardiogram Clinical test (2)Pharmacokinetics blood serum concentration of PC-SOD | — |
Countries
Japan
Outcome results
None listed