Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects

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.

Timeline

Start

2015-05

Primary completion

2015-10

Completion

2015-10

Publications

• Trapnell BC, Carey BC, Robinson BR. Pharmacokinetics and pharmacodynamics of inhaled molgramostim in healthy people. BMJ Open Respir Res. 2025 Sep 18;12(1):e002832. doi: 10.1136/bmjresp-2024-002832.

Drugs

Indications