Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled, single ascending (SAD), and multiple
ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male
and female subjects (on non-child bearing potential) will be enrolled to investigate single
inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses at 2 dose
levels (Part 2). The 2 doses in the multiple ascending dose regimens will be administered
once daily (QD) for 6 consecutive days. The clinical indication for inhaled molgramostim is
the treatment of respiratory diseases such as aPAP, bronchiectasis and cystic fibrosis. The
Clinical trial will involve 42 healthy participants. The trial is expected to last
approximately 4 months.