drugset / Trial / NCT03748199

Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF

NCT03748199 ↗

Phase 1/2 Completed 32 enrolled Santhera Pharmaceuticals
RandomizedSequentialDouble-blindTreatment

Summary

"This is a randomised, double-blind, placebo-controlled multi-centre study to investigate safety and tolerability and to provide pharmacokinetic and pharmacodynamics information of orally inhaled multiple doses (80 mg, 160 mg or 320 mg) of the nebulised neutrophil elastase inhibitor POL6014 in patients with Cystic Fibrosis. The controlled inhalation will occur via the eFlow® nebuliser system (manufacturer: PARI Pharma GmbH, Germany)".

Timeline

Start
2018-11-08
Primary completion
2020-12-30
Completion
2020-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject POL6014 Unknown 40 mg Inhaled
Subject POL6014 Unknown 80 mg Inhaled
Subject POL6014 Unknown 160 mg Inhaled

Indications