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Recruiting Phase 2 NCT07108153

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

Phase 2 – studying effectiveness and dosage
Conditions: Cystic Fibrosis (CF)

Sponsor: Sionna Therapeutics Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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 2
Australia (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
United States (1)
National Jewish Health
Denver , Colorado
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
03.11.2025
Completion date
01.07.2026
Registry ID
NCT07108153
Source
anzctr
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