Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
Royal Brompton Hospital
London, England, United Kingdom
Celerion
Belfast, Northern Ireland, United Kingdom
Incidence of adverse events
To determine the incidence of treatment related adverse events.
Time frame: 8 days
Spirometry
To assess change from baseline spirometry.
Time frame: 8 days
Pulse Oximetry
To assess change in baseline pulse oximetry
Time frame: 8 days
Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
To characterize the pharmacokinetics of SNSP113
Time frame: Days 1, 2 and 8
Area under concentration-time curve from time zero extrapolated to infinity (AUC)
To characterize the pharmacokinetics of SNSP113
Time frame: Days 1, 2 and 8
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