Cystic FibrosisPhase 1NCT03056989
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
A Phase 1 study testing SPX-101 in people with Cystic Fibrosis, run by Spyryx Biosciences, Inc. at 1 site in Canada.
Trial summary
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- SPX-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 31 May 2017to 2 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of CF
- FEV1 ≥ 40% predicted normal
- Stable CF lung disease
- Non-pregnant, non-lactating females
Who cannot join
- Significant unstable co-morbidities within 28 days of screening as judged by the Investigator.
- Has received an investigational drug within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- SPX-101
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPX-101Drug
Inhalation solution twice daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| SPX-101 Low Dose | Experimental | Inhalation Solution twice daily for 7 days. Receives: Drug: SPX-101 |
| SPX-101 Mid Dose | Experimental | Inhalation Solution twice daily for 7 days. Receives: Drug: SPX-101 |
| SPX-101 High Dose | Experimental | Inhalation Solution twice daily for 7 days. Receives: Drug: SPX-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Day 1 through Day 15
Secondary outcomes (2)
Relative change from baseline through Day 8 in percent predicted FEV1
Measured: Screening and Day 1 through Day 8
Change from baseline through Day 8 in clinical laboratory tests
Chemistry, Hematology, Urinalysis
Measured: Screening and Day 1 through Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start31 May 2017
- Primary completion2 Aug 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spyryx Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Tullis, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056989
- Sponsor's protocol ID
- SPX-101-CF-102
- Status last verified
- Sep 2017
- First submitted
- 15 Feb 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31302339
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03056989
- Acronym / sponsor ID
- SPX-101-CF-102
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Spyryx Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 2 Aug 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 17 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SPX-101 Low Dose | Experimental | Drug: SPX-101Inhalation Solution twice daily for 7 days. |
| SPX-101 Mid Dose | Experimental | Drug: SPX-101Inhalation Solution twice daily for 7 days. |
| SPX-101 High Dose | Experimental | Drug: SPX-101Inhalation Solution twice daily for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of CF
- FEV1 ≥ 40% predicted normal
- Stable CF lung disease
- Non-pregnant, non-lactating females
Key exclusion criteria (2 listed)
- Significant unstable co-morbidities within 28 days of screening as judged by the Investigator.
- Has received an investigational drug within the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPX-101Inhalation solution twice daily for 7 days. | Drug | SPX-101 High Dose, SPX-101 Low Dose, SPX-101 Mid Dose |
Primary outcome
Number of participants with adverse events
Time frame: Day 1 through Day 15
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Derived from this study: PubMed 31302339Couroux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Tullis, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPX-101 in people with Cystic Fibrosis, run by Spyryx Biosciences, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Day 1 through Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03056989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.