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

Phase 1

Terminated

• Conditions: Pulmonary Disease; Lung Infection Pseudomonal; Lung Diseases; Respiratory Tract Disease; Antibiotic Resistant Infection; Lung Infection; Lung; Infection, Atypical Mycobacterium; Cystic Fibrosis Pulmonary Exacerbation; Burkholderia Infections; Burkholderia Cepacia Infection
• Interventions: Drug: Inhaled SNSP113; Drug: Inhaled Placebo

• Registration Number: NCT03309358
• Lead Sponsor: Synspira, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-28
• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-13
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-18
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-23
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Inhaled SNSP113	Inhaled SNSP113	-
Inhaled Placebo	Inhaled Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Celerion; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, England, United Kingdom