NCT03748199 - Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 8, 2018

Primary Completion Date

December 30, 2020

Study Completion Date

December 30, 2020

Conditions

Cystic Fibrosis

Interventions

DRUG

POL6014

"DL1 80 mg cohorts 1A and 1B (80 mg QD and 40 mg BID) DL2 160 mg cohorts 2A and 2B (160 mg QD and 80 mg BID) DL3 40 mg QD cohort C~DL = dose Level QD= quaque die (once daily) BID= bis in die (twice daily)"

DRUG

Placebo

Placebo will be administered orally at a dose and frequency matched to POL6014

Trial Locations (4)

13353

Charité - Uniklinik Berlin, Klinik für Pädiatrie,Pneumologie, Immunologie, Erwachsenene-Mucoviszidose, Berlin

45239

Ruhrlandklinik Westdeutsches Lungenzentrum, Essen

60596

IKF Pneumologie GmbH & Co. KG, Institut für klinische Forschung Pneumologie, Frankfurt

82131

Inamed GmbH, clinical unit, Gauting