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

NCT02532764 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-02-06

Study results available
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Summary

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

Conditions

Interventions

DRUG

QR-010

Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton

DRUG

Placebo

Normal Saline

Sponsors & Collaborators

Principal Investigators

  • Stuart Elborn, MD · Trust and Queen's University Belfast

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-09-14
Completion
2017-09-14

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02532764 on ClinicalTrials.gov