Status:
COMPLETED
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Lead Sponsor:
Spyryx Biosciences, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Eligibility Criteria
Inclusion
- Confirmed diagnosis of cystic fibrosis
- ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%
- Stable CF Lung Disease
- Males and non-pregnant, non-lactating females
Exclusion
- Significant unstable co-morbidities within 28 days of screening
- Has received an investigational drug within 28 days of screening
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2019
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03229252
Start Date
August 1 2017
End Date
June 20 2019
Last Update
December 30 2019
Active Locations (25)
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1
University of Calgary Heritage Medical Research Center
Calgary, Alberta, Canada, T2N 1N4
2
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
Ottawa, Ontario, Canada, K1H 8L6
3
Saint Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
4
Hospices Civils de Lyon (HCL)
Pierre-Bénite, Auvergne-Rhône-Alpes, France