Overview

An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Status:
Completed
Trial end date:
2019-06-20
Target enrollment:
0
Participant gender:
All
Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Spyryx Biosciences, Inc.
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- 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 Criteria:

- Significant unstable co-morbidities within 28 days of screening

- Has received an investigational drug within 28 days of screening