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

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    16
  • sponsor
    Sionna Therapeutics Inc.
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Updated on 15 April 2026
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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.

Details
Condition Cystic Fibrosis (CF)
Age 18years - 65years
Clinical Study IdentifierNCT07108153
SponsorSionna Therapeutics Inc.
Last Modified on15 April 2026

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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