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

Study to assess safety and effects of SION-719 with Trikafta.

Recruiting
18-65 years
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study checks how safe and tolerable a new drug, SION-719, is when used with Trikafta, a medicine for cystic fibrosis (CF). It will also study how the drug moves and behaves in the body, known as pharmacokinetics and pharmacodynamics. Participants must have a specific type of CF called F508del homozygous genotype and have been taking Trikafta without changes for at least 3 months. They should not have any recent major health problems.

  • The study involves adding SION-719 to existing Trikafta treatment.
  • Participants must have been stable on Trikafta for at least 3 months.
  • People with certain other illnesses or cancer histories may not join.
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Study details
    Cystic Fibrosis (CF)

NCT07108153

Sionna Therapeutics Inc.

22 April 2026

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