A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis

Study Overview
=================
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.

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)

Conditions
-----------------
Lung Diseases, Pulmonary Disease, Cystic Fibrosis, Cystic Fibrosis Lung, Cystic Fibrosis Pulmonary Exacerbation, Cystic Fibrosis With Exacerbation, Respiratory Tract Disease, Pulmonary Inflammation, Multi-antibiotic Resistance, Antibiotic Resistant Infection, Lung Infection, Lung Infection Pseudomonal, Lung; Infection, Atypical Mycobacterium, Burkholderia Infections, Burkholderia Cepacia Infection, Lung Inflammation

Intervention / Treatment
-----------------
* Drug: Inhaled SNSP113
* Drug: Inhaled Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inhaled SNSP113<br> | Drug: Inhaled SNSP113<br>* A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.<br>|
| Placebo Comparator: Inhaled Placebo<br> | Drug: Inhaled Placebo<br>* A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | To determine the incidence of treatment related adverse events. | 8 days | 
| Spirometry | To assess change from baseline spirometry. | 8 days | 
| Pulse Oximetry | To assess change in baseline pulse oximetry | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax) | To characterize the pharmacokinetics of SNSP113 | Days 1, 2 and 8 | 
| Area under concentration-time curve from time zero extrapolated to infinity (AUC) | To characterize the pharmacokinetics of SNSP113 | Days 1, 2 and 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cystic Fibrosis, Pulmonary exacerbation, Pulmonary inflammation, Respiratory tract disease, Pulmonary disease, Biofilms