This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after administrations of single (SAD) ascending doses in healthy subjects and multiple (MAD) ascending doses in subjects with NCFB.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
64
IKF Pneumologie Institute
Frankfurt, Germany
Medicines Evaluation Unit (MEU)
Manchester, England, United Kingdom
Celerion
Belfast, Northern Ireland, United Kingdom
Number of subjects with treatment emergent adverse events (TEAEs) - overall, severity and causality
Time frame: Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients)
Percent of subjects with TEAEs - overall, severity and causality
Time frame: Up to 8 days (healthy volunteers); Up to 21 days (NCFB patients)
Maximum concentration (Cmax) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Time of maximum concentration (Tmax) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Area under the concentration-time curve from time 0 to 24 hours (AUC0-24h) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Area under the concentration-time curve from time 0 to last quantifiable time point (AUC0-last) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Apparent total clearance of the drug (CL/F) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Apparent volume of distribution during the elimination phase (V/F) of CSL787 in sputum and serum in healthy subjects
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Time frame: Up to 8 days from inhalation
Terminal elimination half-life (T1/2) of CSL787 in sputum and serum in healthy subjects
Time frame: Up to 8 days from inhalation
Cmax of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 1, after dosing
Tmax of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 1, after dosing
Ctrough of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 1, after dosing
AUCtau of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 1, after dosing
Cmax of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
Tmax of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
Ctrough of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
AUCtau of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
T1/2 of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
CL/F of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
V/F of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
Accumulation Ratio (AR) for Cmax of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
AR for Ctrough of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose
AR for AUCtau of CSL787 in sputum and serum of NCFB subjects
Time frame: On Day 14, after last dose