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

Studying SION-719 with Trikafta for safety and bodily effects.

Recruiting
18-65 years
All
Phase 2
**Study Summary** This study is to check if a new medicine, **SION-719**, is safe and works well when added to a medicine called **Trikafta** for people with **Cystic Fibrosis (CF)**. Cystic Fibrosis is a disease that affects the lungs and digestion. **Pharmacodynamics** means how the medicine affects the body, and **Pharmacokinetics** means how the body processes the medicine. **Eligibility:** - You must have a specific type of CF called **F508del homozygous**. - You should have been taking **Trikafta** as prescribed for at least three months. - Your CF must be stable without serious lung issues recently. **Key Points:** - **Study Length:** Details about the study duration will be provided during the screening. - **Visits Required:** Regular visits to the study site will be necessary. - **Risks:** There might be some risks as with any medical study, but safety is a top priority. If you have other serious illnesses or a history of cancer (except some skin cancers that are clear for a year), you may not be able to join. Please consider these points and consult your doctor to decide if this study is right for you.
Study details
    Cystic Fibrosis (CF)

NCT07108153

Sionna Therapeutics Inc.

22 April 2026

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