UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022116 |
|---|---|
| Receipt number | 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 09:08:24 |
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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
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
page-office@umin.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Bioscience Medical Reseach Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025497
