Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Acute Lung Injury
Acute Respiratory Distress Syndrome
Bronchiectasis
Cystic Fibrosis
Pulmonary Alveolar Proteinosis
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn

Clinical Trial Details

NCT number	NCT02468908
Study type	Interventional
Source	Savara Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	May 2015
Completion date	October 2015

View Details

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