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

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.