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SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT02840708
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : December 18, 2017
Information provided by (Responsible Party):
Niigata University Medical & Dental Hospital

Brief Summary:

Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation.

Study Design: Pharmacokinetic open study

Condition or disease Intervention/treatment Phase
Pulmonary Alveolar Proteinosis, Autoimmune Drug: Sargramostim Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
Study Start Date : May 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 125mcg
SK-1401 125mcg single inhalation
Drug: Sargramostim
Active Comparator: 250mcg
SK-1401 250mcg single inhalation
Drug: Sargramostim
Active Comparator: 500mcg
SK-1401 500mcg single inhalation
Drug: Sargramostim

Primary Outcome Measures :
  1. Serum level of Sargramostim [ Time Frame: 0.5,1,2,4,8,12 and 24 hours after inhalation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Exclusion Criteria:

  1. WBC of 12,000/mcl 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
  8. renal dysfunction
  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 medicines (incl. OTC).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840708

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Niigata University Med & Dental Hospital
Niigata, Japan
Sponsors and Collaborators
Niigata University Medical & Dental Hospital
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Responsible Party: Niigata University Medical & Dental Hospital
ClinicalTrials.gov Identifier: NCT02840708    
Other Study ID Numbers: NTU
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Respiratory Aspiration
Pulmonary Alveolar Proteinosis
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Lung Diseases
Immunologic Factors
Physiological Effects of Drugs