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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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

Study Design: Pharmacokinetic open study

Detailed Summary:
Sponsor: Niigata University Medical & Dental Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Niigata University Medical & Dental Hospital

Dates:
Date Received: July 13, 2016
Date Started: May 2016
Date Completion:
Last Updated: December 27, 2016
Last Verified: December 2016