Back to resultsSK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
Primary Purpose
Pulmonary Alveolar Proteinosis, Autoimmune
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Sargramostim
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Alveolar Proteinosis, Autoimmune
Eligibility Criteria
Inclusion Criteria:
- Subjects judged to be appropriate for the study by the attending physician
can provide signed informed consent.
aPAP patient must meet the following
- aPAP patient aged over 20 and below 80 years old (as of the date of registration)
aPAP severity is mild or moderate. (not severe)
Healthy volunteer must meet the following
- Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
- BMI (Body mass index) is between 18 and 25.
Exclusion Criteria:
- WBC of 12,000/mcl or more
- Fever of 38 degree celsius or more
- History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
- Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
- 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.
- History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
- liver dysfunction
- renal dysfunction
- Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
- Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
- allergic to GM-CSF.
- addicted to illegal drugs
- Participation to other clinical trials within 12 weeks before registration.
- smoking within 5 years
cannot follow the procedure defined in this protocol
aPAP patient must exclude the following
- Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
- 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.
taking other inhalation.
Healthy volunteer must exclude the following
- taking any medicines (incl. OTC).
Sites / Locations
- Niigata University Med & Dental Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
125mcg
250mcg
500mcg
Arm Description
SK-1401 125mcg single inhalation
SK-1401 250mcg single inhalation
SK-1401 500mcg single inhalation
Outcomes
Primary Outcome Measures
Serum level of Sargramostim
Secondary Outcome Measures
Full Information
NCT ID
NCT02840708
First Posted
July 13, 2016
Last Updated
December 15, 2017
Sponsor
Niigata University Medical & Dental Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02840708
Brief Title
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
Official Title
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niigata University Medical & Dental Hospital
4. Oversight
5. Study Description
Brief Summary
Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation.
Study Design: Pharmacokinetic open study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Alveolar Proteinosis, Autoimmune
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
125mcg
Arm Type
Active Comparator
Arm Description
SK-1401 125mcg single inhalation
Arm Title
250mcg
Arm Type
Active Comparator
Arm Description
SK-1401 250mcg single inhalation
Arm Title
500mcg
Arm Type
Active Comparator
Arm Description
SK-1401 500mcg single inhalation
Intervention Type
Drug
Intervention Name(s)
Sargramostim
Primary Outcome Measure Information:
Title
Serum level of Sargramostim
Time Frame
0.5,1,2,4,8,12 and 24 hours after inhalation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects judged to be appropriate for the study by the attending physician
can provide signed informed consent.
aPAP patient must meet the following
aPAP patient aged over 20 and below 80 years old (as of the date of registration)
aPAP severity is mild or moderate. (not severe)
Healthy volunteer must meet the following
Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
BMI (Body mass index) is between 18 and 25.
Exclusion Criteria:
WBC of 12,000/mcl or more
Fever of 38 degree celsius or more
History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
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.
History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
liver dysfunction
renal dysfunction
Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
allergic to GM-CSF.
addicted to illegal drugs
Participation to other clinical trials within 12 weeks before registration.
smoking within 5 years
cannot follow the procedure defined in this protocol
aPAP patient must exclude the following
Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
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.
taking other inhalation.
Healthy volunteer must exclude the following
taking any medicines (incl. OTC).
Facility Information:
Facility Name
Niigata University Med & Dental Hospital
City
Niigata
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
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