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

• Inhaled SNSP113 (Drug): A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
• Inhaled Placebo (Drug): A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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.

• Maria Theresa Basco, MD, MPH, Study director, Synspira, Inc.