A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With S… (NCT03309358) | Clinical Trial Compass
TerminatedPhase 1
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Stopped: Successful completion of Part A. Company decision to end early.
United Kingdom32 participantsStarted 2017-09-28
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
* 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.
Exclusion Criteria:
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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.