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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008921
Receipt No. 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

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Basic information
Public title PC-SOD NE (Phase I)
-Repeated Dose Study in healthy volunteers-
Acronym PC-SOD NE (Phase I)
Scientific Title PC-SOD NE (Phase I)
-Repeated Dose Study in healthy volunteers-
Scientific Title:Acronym PC-SOD NE (Phase I)
Region
Japan

Condition
Condition idiopathic pulmonary fibrosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The safety of PC-SOD inhalation
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (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
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PC-SOD NE was inhaled once daily for 7days at repeated doses of 40mg.
Interventions/Control_2 Placebo was inhaled once daily for 7days at repeated doses of 40mg.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male
Key inclusion criteria (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
Key exclusion criteria (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.
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Murakami
Organization LTT Bio Pharma Co., LTD.
Division name Clinical Develpment
Zip code
Address Shiodome Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization LTT Bio Pharma Co., LTD.
Division name Clinical Development
Zip code
Address Shiodome Building 3F 1-2-20 Kaigan, Minato-ku, Tokyo 105-0022 Japan
TEL 03-5733-7394
Homepage URL http://www.ltt.co.jp/
Email

Sponsor
Institute LTT Bio Pharma Co., LTD.
Institute
Department

Funding Source
Organization LTT Bio Pharma Co., LTD.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 09 Month 14 Day
Last modified on
2012 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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