drugset / Trial / NCT02566044
Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis
NaCrossoverDouble-blindTreatment
Summary
This is a study of multiple doses of inhaled QBW276 in patients with cystic fibrosis on top of standard of care. The study was divided into 3 Cohorts. Cohorts 1 and 2 are designed to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled QBW276 over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of their genotype. The study was terminated after Cohort 2 due to the resource issues.
Timeline
- Start
- 2017-09-27
- Primary completion
- 2018-04-24
- Completion
- 2018-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QBW276 | Unknown | 0.3 mg | Inhaled |
| Subject | QBW276 | Unknown | 1.5 mg | Inhaled |
| Subject | QBW276 | Unknown | 3 mg | Inhaled |