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Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis

NCT03903913 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-06-16

No results posted yet for this study

Summary

This is a single center, open label, Phase IIa, multiple-ascending dose study in which subjects with mild to moderate Cystic Fibrosis and non CF bronchiectasis (n≤12) will be enrolled.

The safety and tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered twice daily in subjects with Cystic Fibrosis and non CF bronchiectasis will be evaluated. This will be followed by 5 day consecutive treatment using the highest tolerated dose of S1226. Participants can choose additional use of a further four weeks (28 days) of S-1226 therapy at home, using same or a lower tolerated dose.

Conditions

Interventions

DRUG

S-1226

The drug product S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) nebulized with a medical gas mixture containing CO2. The PFOB component remains the same but the medical gas component contains 4%, 8% or 12% CO2.

Sponsors & Collaborators

  • SolAeroMed Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Montgomery, MD · University of Calgary

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
14 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2022-02-28
Completion
2022-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03903913 on ClinicalTrials.gov