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Study details
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Proof-of-concept Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Sionna Therapeutics Inc.
NCT IDNCT07108153ClinicalTrials.gov data as of Apr 2026
Phase

Phase 2

Target enrollment

16

Study length

about 9 months

Ages

18–65

Locations

10 sites in CO, IA, MA +6

About this study

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).

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo-to-match SION-719
  • 2.Take SION-719
PhasePhase 2
Primary goalTo 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

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low4%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

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

Body systems

Respiratory