Cystic Fibrosis
Conditions
Brief summary
Safety and tolerability, based on the assessment of adverse events (AEs), clinical laboratory values (serum chemistry, hematology, coagulation, and urinalysis), standard 12-lead ECGs, vital signs, pulse oximetry, spirometry, and immune response to VX-522 components and CFTR protein through the Week 8 Visit
Detailed description
MAD T1: Change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) at Day 29, MAD T2: Change from baseline and pre-Run-in baseline in ppFEV1 at Day 29, Safety based on the assessment of AEs, clinical laboratory values (serum chemistry, hematology, coagulation, and urinalysis), standard 12-lead ECGs, vital signs, pulse oximetry, spirometry, and immune response to VX-522 components and CFTR protein through the Safety Follow-up Visit
Interventions
DRUGVX-522 Nebuliser dispersion
Sponsors
Vertex Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, based on the assessment of adverse events (AEs), clinical laboratory values (serum chemistry, hematology, coagulation, and urinalysis), standard 12-lead ECGs, vital signs, pulse oximetry, spirometry, and immune response to VX-522 components and CFTR protein through the Week 8 Visit | — |
Secondary
| Measure | Time frame |
|---|---|
| MAD T1: Change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1) at Day 29, MAD T2: Change from baseline and pre-Run-in baseline in ppFEV1 at Day 29, Safety based on the assessment of AEs, clinical laboratory values (serum chemistry, hematology, coagulation, and urinalysis), standard 12-lead ECGs, vital signs, pulse oximetry, spirometry, and immune response to VX-522 components and CFTR protein through the Safety Follow-up Visit | — |
Countries
Belgium, Germany, Italy, Netherlands, Spain, Sweden
Outcome results
None listed