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

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).