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

September 1, 2017 updated by: Spyryx Biosciences, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • Saint Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Day 1 through Day 15
Day 1 through Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change from baseline through Day 8 in percent predicted FEV1
Time Frame: Screening and Day 1 through Day 8
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
Screening and Day 1 through Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyryx Biosciences, Inc.

Investigators

  • Principal Investigator: Elizabeth Tullis, MD, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2017

Primary Completion (Actual)

August 2, 2017

Study Completion (Actual)

August 2, 2017

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPX-101-CF-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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