Overview

A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Status:
Completed
Trial end date:
2017-08-02
Target enrollment:
0
Participant gender:
All
Summary
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Spyryx Biosciences, Inc.
Treatments:
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Confirmed diagnosis of CF

- FEV1 ≥ 40% predicted normal

- Stable CF lung disease

- Non-pregnant, non-lactating females

Exclusion Criteria:

- Significant unstable co-morbidities within 28 days of screening as judged by the
Investigator.

- Has received an investigational drug within the past 30 days