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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056989
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date September 5, 2017
Actual Study Start Date  ICMJE May 31, 2017
Actual Primary Completion Date August 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
Number of participants with adverse events [ Time Frame: Day 1 through Day 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2017)
  • Relative change from baseline through Day 8 in percent predicted FEV1 [ Time Frame: Screening and Day 1 through Day 8 ]
  • Change from baseline through Day 8 in clinical laboratory tests [ Time Frame: Screening and Day 1 through Day 8 ]
    Chemistry, Hematology, Urinalysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Official Title  ICMJE A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Brief Summary Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Drug: SPX-101
Inhalation solution twice daily for 7 days.
Study Arms  ICMJE
  • Experimental: SPX-101 Low Dose
    Inhalation Solution twice daily for 7 days.
    Intervention: Drug: SPX-101
  • Experimental: SPX-101 Mid Dose
    Inhalation Solution twice daily for 7 days.
    Intervention: Drug: SPX-101
  • Experimental: SPX-101 High Dose
    Inhalation Solution twice daily for 7 days.
    Intervention: Drug: SPX-101
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
5
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2, 2017
Actual Primary Completion Date August 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056989
Other Study ID Numbers  ICMJE SPX-101-CF-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Spyryx Biosciences, Inc.
Study Sponsor  ICMJE Spyryx Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elizabeth Tullis, MD Unity Health Toronto
PRS Account Spyryx Biosciences, Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP