NCT07108153

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

A Phase 2a Randomized, Double-blind, Placebo-controlled Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Physician-prescribed Trikafta® in People With Cystic Fibrosis Who Are Homozygous for the F508del Mutation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Sionna Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.

Conditions

• Cystic Fibrosis (CF)

Interventions

Type	Name	Description
DRUG	SION-719	All participants receive SION-719, as specified by their treatment sequence assignment
DRUG	Placebo-to-match SION-719	All participants receive placebo to match SION-719, as specified by their treatment sequence assignment

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-08-06
• Last updated: 2026-03-02

Locations

13 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study