Antibiotic Resistant Infection, Burkholderia Cepacia Infection, Burkholderia Infections, Cystic Fibrosis, Cystic Fibrosis Lung, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis With Exacerbation, Lung Diseases, Lung Infection, Lung; Infection, Atypical Mycobacterium, Lung Infection Pseudomonal, Lung Inflammation, Multi-antibiotic Resistance, Pulmonary Disease, Pulmonary Inflammation, Respiratory Tract Disease
Conditions
Keywords
Cystic Fibrosis, Pulmonary exacerbation, Pulmonary inflammation, Respiratory tract disease, Pulmonary disease, Biofilms
Brief 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.
Interventions
DRUGInhaled SNSP113
A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
DRUGInhaled Placebo
A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
Sponsors
Synspira, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 8 days | To determine the incidence of treatment related adverse events. |
| Spirometry | 8 days | To assess change from baseline spirometry. |
| Pulse Oximetry | 8 days | To assess change in baseline pulse oximetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax) | Days 1, 2 and 8 | To characterize the pharmacokinetics of SNSP113 |
| Area under concentration-time curve from time zero extrapolated to infinity (AUC) | Days 1, 2 and 8 | To characterize the pharmacokinetics of SNSP113 |
Countries
United Kingdom
Outcome results
None listed