Title
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
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)
Phase
Phase 1Lead Sponsor
Synspira, Inc.Study Type
InterventionalStatus
TerminatedIndication/Condition
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
Inhaled SNSP113 ...Study Participants
32Although 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.
A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
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.
