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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.

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: SPX-101 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: SPX-101 Low Dose
Inhalation Solution twice daily for 7 days.
 Drug: SPX-101
Inhalation solution twice daily for 7 days.
Experimental: SPX-101 Mid Dose
Inhalation Solution twice daily for 7 days.
 Drug: SPX-101
Inhalation solution twice daily for 7 days.
Experimental: SPX-101 High Dose
Inhalation Solution twice daily for 7 days.
 Drug: SPX-101
Inhalation solution twice daily for 7 days.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Day 1 through Day 15 ]

Secondary Outcome Measures :
  1. Relative change from baseline through Day 8 in percent predicted FEV1 [ Time Frame: Screening and Day 1 through Day 8 ]
  2. Change from baseline through Day 8 in clinical laboratory tests [ Time Frame: Screening and Day 1 through Day 8 ]
    Chemistry, Hematology, Urinalysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056989


Locations
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Canada, Ontario
Saint Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
Spyryx Biosciences, Inc.
Investigators
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Principal Investigator: Elizabeth Tullis, MD St. Michael's Hospital, Toronto
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Spyryx Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03056989    
Other Study ID Numbers: SPX-101-CF-102
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases