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Keep this study
Lead
ProQR Therapeutics
With
European Commission
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.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Breast-feeding or pregnant
Use of lumacaftor or ivacaftor
Use of any investigational drug or device
History of lung transplantation
Hemoptysis
Clareo Health | Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients
