Safety, tolerability, PK and PD study of inhaled molgramostim
Research type
Research Study
Full 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 Molgramostim when Administered by Inhalation to Healthy Adult Subjects
IRAS ID
176938
Contact name
Adrian/J Stewart
Contact email
Sponsor organisation
Serendex Pharmaceuticals A/S
Eudract number
2013-001687-32
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD), and multiple ascending dose (MAD) study conducted at a single clinical site within the UK. Healthy male and female subjects (of non-child bearing potential) will be enrolled to investigate single inhaled doses of molgramostim at 3 dose levels (Part 1) and multiple inhaled doses of molgramostim 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 (BE) and cystic fibrosis (CF). The Clinical trial will involve 48 healthy male and female participants (of non-child bearing potential) at one Clinical Trial Site in the UK. The Clinical Trial is expected to last approximately 4 months.
REC name
HSC REC B
REC reference
15/NI/0037
Date of REC Opinion
27 Mar 2015
REC opinion
Further Information Favourable Opinion