NCT03309358TerminatedPhase 1
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)
Synspira, Inc.2 sites in 1 country32 target enrollmentStarted: September 28, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Incidence of adverse events
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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
- •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.
- •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.
Arms & Interventions
Inhaled SNSP113
Experimental
Intervention: Inhaled SNSP113 (Drug)
Inhaled Placebo
Placebo Comparator
Intervention: Inhaled Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: 8 days
To determine the incidence of treatment related adverse events.
Spirometry
Time Frame: 8 days
To assess change from baseline spirometry.
Pulse Oximetry
Time Frame: 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)
- Area under concentration-time curve from time zero extrapolated to infinity (AUC)(Days 1, 2 and 8)
Investigators
Study Sites (2)
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