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

NCT07108153 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Sionna Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sionna Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-03
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07108153 on ClinicalTrials.gov