Unique ID issued by UMIN | UMIN000008921 |
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Receipt number | R000010328 |
Scientific Title | PC-SOD NE (Phase I) -Repeated Dose Study in healthy volunteers- |
Date of disclosure of the study information | 2012/09/14 |
Last modified on | 2012/09/12 16:47:37 |
PC-SOD NE (Phase I)
-Repeated Dose Study in healthy volunteers-
PC-SOD NE (Phase I)
PC-SOD NE (Phase I)
-Repeated Dose Study in healthy volunteers-
PC-SOD NE (Phase I)
Japan |
idiopathic pulmonary fibrosis
Pneumology |
Others
NO
The safety of PC-SOD inhalation
Pharmacokinetics
(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
Interventional
Parallel
Randomized
Single blind -participants are blinded
Placebo
NO
2
Treatment
Medicine |
PC-SOD NE was inhaled once daily for 7days at repeated doses of 40mg.
Placebo was inhaled once daily for 7days at repeated doses of 40mg.
20 | years-old | <= |
50 | years-old | >= |
Male
(1)Sex: Male
(2)Age:20-50 years
(3)Japanese
(4)All paatients must provide written informed consent
(5)Patients who the principal investigator or the investigator judges medically suitable for inclusion in the clinicak investigation based on examination at screening conduceted within 28 days prior to study drug administration
(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.
8
1st name | |
Middle name | |
Last name | Masahiro Murakami |
LTT Bio Pharma Co., LTD.
Clinical Develpment
Shiodome Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
1st name | |
Middle name | |
Last name |
LTT Bio Pharma Co., LTD.
Clinical Development
Shiodome Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
03-5733-7394
http://www.ltt.co.jp/
LTT Bio Pharma Co., LTD.
LTT Bio Pharma Co., LTD.
Self funding
NO
2012 | Year | 09 | Month | 14 | Day |
Published
Completed
2010 | Year | 11 | Month | 24 | Day |
2010 | Year | 12 | Month | 21 | Day |
2012 | Year | 09 | Month | 14 | Day |
2012 | Year | 09 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010328
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