HYPOCHLOROUS ACID for Chronic airway infections | Cystic fibrosis | Primary ciliary dyskinesia | Non-CF bronchiectasis

Inclusion criteria

• {"criterion_text":"- Phase 1: Participants are eligible to participate in the dose-escalation part of the trial if they are healthy, between 18 and 55 years of age, and have a Body Mass Index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2"}
• {"criterion_text":"- Phase 2a: Adult CF/PCD/NCFB patients with chronic airway infection are eligible to participate in the PoC part of the trial if their underlying CF/PCD/NCFB disease is stable and they are able to spontaneously expectorate >1 g sputum with a bacterial density of at least 5 log10 colony-forming units (CFU) per g"}

Exclusion criteria

• {"criterion_text":"- Phase 1: Participants are not eligible to participate in the dose-escalation part of the trial if they have recently participated in another clinical trial or have donated blood; are pregnant or lactating; have a medical condition or a history of drug hypersensitivity; are using concomitant medication."}
• {"criterion_text":"- Phase 2a: CF/PCD/NCFB patients are not eligible to participate in the PoC part of the trial if their forced expiratory volume (FEV1) is below 30% of predicted or their oxygen saturation is below 90% determined by pulse oximetry; if they have recently participated in another clinical trial or have donated blood; are pregnant or lactating; have a medical condition other than their underlying CF/PCD/NCFB disease which in the opinion of the investigator precludes participation in the trial; have a history of drug hypersensitivity."}

Primary endpoints

• {"endpoint_text":"- Phase 1: The primary endpoint in the dose-escalation part of the trial is the nature, incidence, and severity of adverse events (AEs)","definition_or_measurement_approach":"Assessment and reporting of adverse events including their nature, incidence and severity as captured during the dose-escalation part of the trial."}
• {"endpoint_text":"- Phase 2a: The primary endpoint in the PoC part of the trial is the change from baseline in log10-transformed sputum density of bacteria following treatment","definition_or_measurement_approach":"Change from baseline in log10-transformed sputum bacterial density (CFU/g) following treatment; reduction in sputum density of bacteria as measured in collected sputum samples."}

Denmark

Earliest CTIS Part Ii Submission Date

18-12-2025

Latest Decision Or Authorization Date

13-02-2026

Processing Time Days

57

Number Of Sites

1

Number Of Participants

55

Primary sponsor

Full Name

Softox Solutions AS

Organisation Type

Pharmaceutical company

Country Of Registered Address

Norway

Third parties

• {"country":"Denmark","full_name":"Billev Pharma ApS","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}