Back to resultsA Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
SPX-101
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility 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
Sites / Locations
- Saint Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SPX-101 Low Dose
SPX-101 Mid Dose
SPX-101 High Dose
Arm Description
Inhalation Solution twice daily for 7 days.
Inhalation Solution twice daily for 7 days.
Inhalation Solution twice daily for 7 days.
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Secondary Outcome Measures
Relative change from baseline through Day 8 in percent predicted FEV1
Change from baseline through Day 8 in clinical laboratory tests
Chemistry, Hematology, Urinalysis
Full Information
NCT ID
NCT03056989
First Posted
February 15, 2017
Last Updated
September 1, 2017
Sponsor
Spyryx Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03056989
Brief Title
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Official Title
A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
August 2, 2017 (Actual)
Study Completion Date
August 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spyryx Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPX-101 Low Dose
Arm Type
Experimental
Arm Description
Inhalation Solution twice daily for 7 days.
Arm Title
SPX-101 Mid Dose
Arm Type
Experimental
Arm Description
Inhalation Solution twice daily for 7 days.
Arm Title
SPX-101 High Dose
Arm Type
Experimental
Arm Description
Inhalation Solution twice daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
SPX-101
Intervention Description
Inhalation solution twice daily for 7 days.
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Day 1 through Day 15
Secondary Outcome Measure Information:
Title
Relative change from baseline through Day 8 in percent predicted FEV1
Time Frame
Screening and Day 1 through Day 8
Title
Change from baseline through Day 8 in clinical laboratory tests
Description
Chemistry, Hematology, Urinalysis
Time Frame
Screening and Day 1 through Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Tullis, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
31302339
Citation
Couroux P, Farias P, Rizvi L, Griffin K, Hudson C, Crowder T, Tarran R, Tullis E. First clinical trials of novel ENaC targeting therapy, SPX-101, in healthy volunteers and adults with cystic fibrosis. Pulm Pharmacol Ther. 2019 Oct;58:101819. doi: 10.1016/j.pupt.2019.101819. Epub 2019 Jul 11.
Results Reference
derived
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A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
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