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NCT03056989 Clinical Trial

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

Cystic Fibrosis Clinical Trial

Official title:
A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03056989
Other study ID # SPX-101-CF-102
Secondary ID
Status Completed
Phase Phase 1
First received February 15, 2017
Last updated September 1, 2017
Start date May 31, 2017
Est. completion date August 2, 2017

Study information
Verified date September 2017
Source Spyryx Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date August 2, 2017
Est. primary completion date August 2, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SPX-101
Inhalation solution twice daily for 7 days.

Locations
Country Name City State
Canada Saint Michael's Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
Spyryx Biosciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events Day 1 through Day 15
Secondary Relative change from baseline through Day 8 in percent predicted FEV1 Screening and Day 1 through Day 8
Secondary Change from baseline through Day 8 in clinical laboratory tests Chemistry, Hematology, Urinalysis Screening and Day 1 through Day 8
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