CompletedPhase 1

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

Japan14 participantsStarted 2016-05

Plain-language summary

Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation. Study Design: Pharmacokinetic open study

Age range20 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects judged to be appropriate for the study by the attending physician
✓. can provide signed informed consent.
✓. aPAP patient aged over 20 and below 80 years old (as of the date of registration)
✓. aPAP severity is mild or moderate. (not severe)
✓. 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.

✕. 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

Serum level of Sargramostim

Timeframe: 0.5,1,2,4,8,12 and 24 hours after inhalation

NCT IDNCT02840708

SponsorNiigata University Medical & Dental Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12

Who can participate

Age range20 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects judged to be appropriate for the study by the attending physician
✓. can provide signed informed consent.
✓. aPAP patient aged over 20 and below 80 years old (as of the date of registration)
✓. aPAP severity is mild or moderate. (not severe)
✓. 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.

✕. 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