Lung DiseasesPhase 1NCT03309358
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
A Phase 1 study testing Inhaled SNSP113 in people with Lung Diseases and Pulmonary Disease, run by Synspira, Inc. at 2 sites in United Kingdom.
Trial summary
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis
- What is being tested?
- Inhaled SNSP113
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 28 Sep 2017to 18 Dec 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A
- Healthy male adults ≥18 and ≤50 years of age at screening.
- Baseline FEV1 80-120% of predicted at Screening.
- Oxygen saturation of ≥ 96% on room air as determined by pulse oximetry at Screening.
- Screening laboratory tests within normal limits.
- Part B
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- Female and Male subjects who are ≥18 years of age and a confirmed diagnosis of CF.
- FEV1 >50% of predicted.
- Oxygen saturation of ≥ 94% on room air as determined by pulse oximetry at Screening.
- Stable CF pulmonary disease as judged by the Investigator.
Who cannot join
- Part A
- Any history of any form of lung disease or any systemic disease that may affect the lung or pulmonary function.
- Former regular smoker or has smoked tobacco or cannabis products within the last 30 days.
- Any history of any form of liver disease, renal disease, cardiac disease, hematologic disease, neurologic disease, atopy or any chronic condition.
- Participation in one or more healthy subject studies within the prior 3 months.
- Part B
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- Participation in a clinical trial involving receipt of an investigational product within the 30 days prior to screening.
- Female subjects who are pregnant (a negative serum pregnancy test must be demonstrated at screening), have a positive pregnancy test, are lactating or who plan to become pregnant within 90 days after dosing.
- Subjects requiring supplemental oxygen.
- Hemoptysis of >5 mL within 12 weeks of screening.
- Listed for organ transplantation.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Celerion
Belfast, Northern Ireland, BT9 6AD
Royal Brompton Hospital
London, England, SW3 6NP
About this study
Official title: A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis With Exacerbation
- Being tested
- Inhaled SNSP113, Inhaled Placebo
- Keywords
- Cystic Fibrosis, Pulmonary exacerbation, Pulmonary inflammation, Respiratory tract disease, Pulmonary disease, Biofilms
- Medical subject headings
- Lung Diseases, Cystic Fibrosis, Respiratory Tract Diseases, Pneumonia, Infections, Mycobacterium Infections, Nontuberculous, Burkholderia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled SNSP113Drug
A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
Inhaled PlaceboDrug
A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled SNSP113 | Experimental | Not described Receives: Drug: Inhaled SNSP113 |
| Inhaled Placebo | Placebo comparator | Not described Receives: Drug: Inhaled Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
To determine the incidence of treatment related adverse events.
Measured: 8 days
Spirometry
To assess change from baseline spirometry.
Measured: 8 days
Pulse Oximetry
To assess change in baseline pulse oximetry
Measured: 8 days
Secondary outcomes (2)
Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
To characterize the pharmacokinetics of SNSP113
Measured: Days 1, 2 and 8
Area under concentration-time curve from time zero extrapolated to infinity (AUC)
To characterize the pharmacokinetics of SNSP113
Measured: Days 1, 2 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start28 Sep 2017
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
Why it stopped: Successful completion of Part A. Company decision to end early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- This is a multiple-site, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to assess the safety and tolerability of inhaled SNSP113 in healthy subjects (Part A) and subjects with stable CF (Part B).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synspira, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Theresa Basco, MD, MPH, Study director, Synspira, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309358
- Sponsor's protocol ID
- SNSP113-17-101
- Status last verified
- May 2018
- First submitted
- 5 Oct 2017
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)
- ClinicalTrials.gov ID
- NCT03309358
- Acronym / sponsor ID
- SNSP113-17-101
- Conditions
- Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis With Exacerbation
- Keywords
- Cystic Fibrosis, Pulmonary exacerbation, Pulmonary inflammation, Respiratory tract disease, Pulmonary disease, Biofilms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Successful completion of Part A. Company decision to end early.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Synspira, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 13 Oct 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.
Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a multiple-site, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to assess the safety and tolerability of inhaled SNSP113 in healthy subjects (Part A) and subjects with stable CF (Part B).
| Arm | Type | Receives |
|---|---|---|
| Inhaled SNSP113 | Experimental | Drug: Inhaled SNSP113 |
| Inhaled Placebo | Placebo comparator | Drug: Inhaled Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Part A
- Healthy male adults ≥18 and ≤50 years of age at screening.
- Baseline FEV1 80-120% of predicted at Screening.
- Oxygen saturation of ≥ 96% on room air as determined by pulse oximetry at Screening.
- Screening laboratory tests within normal limits.
Key exclusion criteria (11 listed)
- Part A
- Any history of any form of lung disease or any systemic disease that may affect the lung or pulmonary function.
- Former regular smoker or has smoked tobacco or cannabis products within the last 30 days.
- Any history of any form of liver disease, renal disease, cardiac disease, hematologic disease, neurologic disease, atopy or any chronic condition.
- Participation in one or more healthy subject studies within the prior 3 months.
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 |
|---|---|---|
| Inhaled SNSP113A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis. | Drug | Inhaled SNSP113 |
| Inhaled PlaceboA single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis. | Drug | Inhaled Placebo |
Primary outcome
Incidence of adverse events
Time frame: 8 days
To determine the incidence of treatment related adverse events.
Spirometry
Time frame: 8 days
To assess change from baseline spirometry.
Pulse Oximetry
Time frame: 8 days
To assess change in baseline pulse oximetry
2 secondary outcomes
Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
Time frame: Days 1, 2 and 8
Area under concentration-time curve from time zero extrapolated to infinity (AUC)
Time frame: Days 1, 2 and 8
Results and safety
The study was stopped early (reason given: Successful completion of Part A. Company decision to end early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2018.
- Individual participant dataSharing planned: No
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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.
Maria Theresa Basco, MD, MPH study director
Synspira, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inhaled SNSP113 in people with Lung Diseases and Pulmonary Disease, run by Synspira, Inc. at 2 sites in United Kingdom.
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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 25 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Successful completion of Part A. Company decision to end early.). Results are not available in the source record.
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?
Incidence of adverse events (time frame: 8 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2018.