A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: SPX-101 | Phase 1 |
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 |

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.
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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. |
- Number of participants with adverse events [ Time Frame: Day 1 through Day 15 ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Canada, Ontario | |
Saint Michael's Hospital | |
Toronto, Ontario, Canada, M5B1W8 |
Principal Investigator: | Elizabeth Tullis, MD | St. Michael's Hospital, Toronto |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |