NCT02532764

Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients

Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QR-010 in Subjects With Homozygous ΔF508 Cystic Fibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: ProQR Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.

Detailed description

The purpose of this study is to evaluate the safety, tolerability, and to determine the pharmacokinetics of QR-010 administered via inhalation in adult homozygous for ΔF508 Cystic Fibrosis.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	QR-010	Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton
DRUG	Placebo	Normal Saline

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-09-14
• Completion: 2017-09-14
• First posted: 2015-08-26
• Last updated: 2019-02-06
• Results posted: 2019-02-06

Locations

27 sites across 10 countries: United States, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Spain, United Kingdom