Cystic fibrosis
Conditions
Brief summary
Incidence, nature, and severity of adverse events (AEs), AEs of Special Interest (AESIs) and serious adverse events (SAEs), Changes from baseline in vital signs, clinical laboratory values, electrocardiogram (ECG), physical examination, sputum microbiology, and pulmonary function., Immunogenicity
Detailed description
Characterize the PK parameters based on concentration in plasma, Measure the concentrations of SPL84 in urine, Spirometry: − Forced expiratory volume in 1 second (FEV1); − Forced vital capacity (FVC); − Forced mid-expiratory flow (FEF25-75)., Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS), Body weight, Change in antibiotic treatment
Interventions
DRUGPlacebo solution for inhalation
Sponsors
Splisense Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, and severity of adverse events (AEs), AEs of Special Interest (AESIs) and serious adverse events (SAEs), Changes from baseline in vital signs, clinical laboratory values, electrocardiogram (ECG), physical examination, sputum microbiology, and pulmonary function., Immunogenicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the PK parameters based on concentration in plasma, Measure the concentrations of SPL84 in urine, Spirometry: − Forced expiratory volume in 1 second (FEV1); − Forced vital capacity (FVC); − Forced mid-expiratory flow (FEF25-75)., Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS), Body weight, Change in antibiotic treatment | — |
Countries
Czechia, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Slovakia, Spain
Outcome results
None listed