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

NCT07108153

CompletedPhase 2

Sponsor: Sionna Therapeutics Inc.

Conditions: Cystic Fibrosis (CF)

Interventions: SION-719, Placebo-to-match SION-719

Countries: United States, Australia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosis of CF with F508del homozygous genotype based on documented CFTR genotype laboratory report.
* Adherent to physician-prescribed Trikafta, as assessed by the Investigator, for at least 3 months prior to the Screening visit, taken at the recommended dose without modifications and on the regimen described in the current prescribing information.
* Stable CF disease without pulmonary exacerbation within 28 days before Baseline or acute non-CF-related illness within 14 days before Baseline.

Exclusion Criteria:

* Participant has clinically significant current or recurrent illness, other than CF
* Participant has a history of malignancy, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of recurrence for at least 1 year.

Locations (13)

Denver, Colorado, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Hawthorne, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Southport, Queensland, Australia
Melbourne, Victoria, Australia