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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022116
Receipt No. R000025497
Scientific Title SK-1401 (rhGM-CSF agent for inhalation) GM-CSF Inhalation Pharmacokinetic study (NTU Trial)
Date of disclosure of the study information 2016/06/01
Last modified on 2017/10/18

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Basic information
Public title SK-1401 (rhGM-CSF agent for inhalation)
GM-CSF Inhalation Pharmacokinetic study
(NTU Trial)
Acronym SK-1401 (rhGM-CSF agent for inhalation)
GM-CSF Inhalation Pharmacokinetic study
(NTU Trial)
Scientific Title SK-1401 (rhGM-CSF agent for inhalation)
GM-CSF Inhalation Pharmacokinetic study
(NTU Trial)
Scientific Title:Acronym SK-1401 (rhGM-CSF agent for inhalation)
GM-CSF Inhalation Pharmacokinetic study
(NTU Trial)
Region
Japan

Condition
Condition autoimmune pulmonary alveolar proteinosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Evaluate PK (0.5, 1, 2, 4, 8, 12 and 24 hours after inhalation).
Key secondary outcomes Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 125ug Single dose
Interventions/Control_2 250ug Single dose
Interventions/Control_3 500ug Single dose
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Subjects judged to be appropriate for the study by the attending physician
2. can provide signed informed consent.

aPAP patient must meet the following
3.aPAP patient aged over 20 and below 80 years old (as of the date of registration)
4.aPAP severity is mild or moderate. (not severe)

Healthy volunteer must meet the following
5. Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
6.BMI (Body mass index) is between 18 and 25.
Key exclusion criteria 1. WBC of 12000/ul or more
2. Fever of 38 degree celsius or more
3. History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
4. Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
5. Complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), interstitial pneumonitis, lung fibrosis or bronchiectasis, in which the evaluations of safety of GM-CSF therapy are considered to be difficult.
6. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
7. liver dysfunction (CTCAE Grade 1 or higher)
8. renal dysfunction (CTCAE Grade 1 or higher)
9. Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
10. Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
11. allergic to GM-CSF.
12. addicted to illegal drugs
13. Participation to other clinical trials within 12 weeks before registration.
14. smoking within 5 years
15.cannot follow the procedure defined in this protocol


aPAP patient must exclude the following
16. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
17. Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, GM-CSF or rituximab within 6 months before the start of the study.
18. taking other inhalation.

Healthy volunteer must exclude the following
19.taking any prescribed medicines.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh Nakata
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Reseach Center
Zip code
Address 1-754, Asahimachi dori, Chuo-ku, Niigata
TEL 025-227-0847
Email radical@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Ueda
Organization Niigata University Medical and Dental Hospital
Division name Bioscience Medical Reseach Center
Zip code
Address 1-754, Asahimachi dori, Chuo-ku, Niigata
TEL 025-227-2331
Homepage URL
Email page-office@umin.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Bioscience Medical Reseach Center
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 新潟大学医歯学総合病院(新潟県)
東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2016 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 20 Day
Last follow-up date
2016 Year 09 Month 20 Day
Date of closure to data entry
2016 Year 10 Month 30 Day
Date trial data considered complete
2016 Year 11 Month 30 Day
Date analysis concluded
2017 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 28 Day
Last modified on
2017 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025497

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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