Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed diagnosis of CF as defined by both of the following:
* Two CF disease-causing cystic fibrosis transmembrane conductance regulator (CFTR) mutations in Class I or II (genotype confirmed at the screening visit).
Clinically stable CF disease, as judged by the investigator.
Forced expiratory volume in 1 second (FEV1) ≥50% and ≤90% of the predicted normal for age, gender, and height at screening.
Resting oxygen saturation ≥92% on room air (pulse oximetry).
You may not be if
An acute upper or lower respiratory infection, pulmonary exacerbation, or clinically significant episode of hemoptysis or change in chronic respiratory medications (including antibiotics) for CF lung disease within 28 days prior to dosing with investigational product on Day 1.
Participants were receiving treatment with ivacaftor monotherapy (KALYDECO).
Parts A and B only: Were receiving treatment with triple combination therapy (TRIKAFTA).
Participants with a Class III, IV, or V CFTR gene mutation in at least 1 allele.
Infection with highly virulent bacteria associated with accelerated decline in pulmonary function and/or decreased survival (e.g., Burkholderia cenocepacia, Burkholderia dolosa, Mycobacterium abscessus).
Treatment with ORKAMBI or SYMDEKO was not an exclusion for this study.
Clareo Health | Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
