Trials / Completed
CompletedNCT02468908
Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects
A Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramostim When Administered by Inhalation to Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Savara Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Molgramostim | |
| DRUG | Placebo |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2015-06-11
- Last updated
- 2017-02-23
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02468908. Inclusion in this directory is not an endorsement.