Clinical Trial: Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramost
Brief 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.
Detailed Summary:
Sponsor: Savara Inc.
Current Primary Outcome: Number and severity of treatment-emergent Adverse Events (AEs) following single and multiple inhaled doses of molgramostim [ Time Frame: 1-6 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- PK parameters: Area under the plasma concentration time curve (AUC), Peak Peak Plasma concentration - Cmax, Time to reach maximum observed serum concentration - tmax [ Time Frame: 1-6 days ]
- PK parameters: Apparent terminal elimination rate constant - k(el) and Apparent terminal elimination rate constant - t(1/2) [ Time Frame: 1-6 days ]
Original Secondary Outcome: Same as current
Information By: Savara Inc.
Dates:
Date Received: June 3, 2015
Date Started: May 2015
Date Completion:
Last Updated: February 20, 2017
Last Verified: November 2015
