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RECRUITING
NCT07108153
PHASE2

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

Sponsor: Sionna Therapeutics Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2025-11-03

Completion Date

2026-07

Last Updated

2026-03-02

Healthy Volunteers

No

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

Locations (13)

National Jewish Health

Denver, Colorado, United States

University of Iowa

Iowa City, Iowa, United States

Johns Hopkins

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

New York Medical College

Hawthorne, New York, United States

Columbia University

New York, New York, United States

University Hospital of Cleveland

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Washington

Seattle, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

Monash University

Melbourne, Victoria, Australia