A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT ID: NCT03056989
Last Updated: 2017-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2017-05-31
2017-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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SPX-101 Low Dose
Inhalation Solution twice daily for 7 days.
SPX-101
Inhalation solution twice daily for 7 days.
SPX-101 Mid Dose
Inhalation Solution twice daily for 7 days.
SPX-101
Inhalation solution twice daily for 7 days.
SPX-101 High Dose
Inhalation Solution twice daily for 7 days.
SPX-101
Inhalation solution twice daily for 7 days.
Interventions
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SPX-101
Inhalation solution twice daily for 7 days.
Eligibility Criteria
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Inclusion Criteria
* FEV1 ≥ 40% predicted normal
* Stable CF lung disease
* Non-pregnant, non-lactating females
Exclusion Criteria
* Has received an investigational drug within the past 30 days
18 Years
50 Years
ALL
No
Sponsors
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Spyryx Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Tullis, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Saint Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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SPX-101-CF-102
Identifier Type: -
Identifier Source: org_study_id
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