Proof-of-concept Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
Phase 2
16
about 9 months
18–65
10 sites in CO, IA, MA +6
What this study is about
This trial is testing a treatment called SION-719 when added to Trikafta in people with cystic fibrosis. The goal is to see if this new treatment is safe and well-tolerated, how it works in the body (pharmacokinetics), and how it affects the body (pharmacodynamics).
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo-to-match SION-719
- 2.Take SION-719
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] when SION-719 is administered to people with cystic fibrosis (CF) who are taking a standard stable dose of physician-prescribed Trikafta
Secondary: Change from baseline in sweat chloride levels
Respiratory