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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:2/8/2019
Start Date:June 2015
End Date:September 14, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

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

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

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.

Inclusion Criteria:

- Confirmed diagnosis of CF as defined by iontophoretic pilocarpine sweat chloride test
(sweat chloride) of > 60 mmol/L

- Confirmation of CFTR gene mutations homozygous for the ΔF508 mutation

- Body mass index (BMI) ≥ 17 kg/m2

- Non-smoking for a minimum of two years

- FEV1 ≥70% of predicted normal for age, gender, and height, at Screening

- Stable lung function

- Adequate hepatic and renal function

Exclusion Criteria:

- Breast‐feeding or pregnant

- Use of lumacaftor or ivacaftor

- Use of any investigational drug or device

- History of lung transplantation

- Hemoptysis
We found this trial at
13
sites
Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Daniel Rosenbluth, MD
Phone: 314-747-2707
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Isabel Neuringer, MD
Phone: 617-726-3719
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Boston, MA
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Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Karen McCoy, MD
Phone: 614-722-4756
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Alicia Casey, MD
Phone: 617-355-6665
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Universitair Ziekenhuis Brussel
Brussels,
Principal Investigator: Anne Malfroot, Professor
Phone: 0032 02 476 3669
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Brussels,
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Patrick Flume, MD
Phone: 843-792-6648
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Northwestern University
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Manu Jain, MD
Phone: 312-926-5610
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Chicago, IL
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Raksha Jain, MD
Phone: 214-648-2817
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Penn State Milton S. Hershey Medical Center
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Robert Vender, MD
Phone: 717-531-5646
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas
Principal Investigator: Joel Mermis, MD
Phone: 913-588-1572
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Kansas City, KS
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University of Southern California USC - Keck School of Medicine
1975 Zonal Avenue
Los Angeles, California 90033
Principal Investigator: Adupa Rao, MD
Phone: 323-409-5383
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Los Angeles, CA
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Stanford University
Palo Alto, California 94304
Principal Investigator: Richard Moss, MD
Phone: 650-736-0388
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Palo Alto, CA
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University of Washington Medical Center
1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Moira Aitken, MD
Phone: 206-685-3995
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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