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

• Status: Terminated
• Trial end date: 2017-12-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Synspira, Inc.

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.