A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis
Study design (if review, criteria of inclusion for studies)
Controlled: Yes.1 Randomised: Yes.2 Open: No.3 Single blind: No.4 Double blind: Yes.5 Parallel group: Yes.6 Cross over: No
Participants
Principal inclusion criteria: 1. Male and female subjects 18 to 65 years of age (inclusive), on the day of signing informed consent; Stable pulmonary symptoms associated with CF for 28 days prior to Screening
Interventions
multiple ascending doses (MAD) of inhaled SNSP113 administered once-daily for 28 days to adult Cystic Fibrosis (CF) subjects.
Outcome measures
Primary end point(s): ⢠Vital signs (blood pressure, heart rate, respiratory rate) ⢠Clinical laboratory evaluations (hematology included complete blood cell count (CBC) with differential and platelet count, serum biochemistry including blood urea nitrogen and creatinine, liver function tests, coagulation profile, and urinalysis) ⢠ECG parameters ⢠Pulmonary function assessed by spirometry, pulse oximetry ⢠PE