NCT03309358

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Synspira, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Diseases
• Pulmonary Disease
• Cystic Fibrosis
• 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

Interventions

Type	Name	Description
DRUG	Inhaled SNSP113	A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
DRUG	Inhaled Placebo	A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.

Timeline

• Start date: 2017-09-28
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2017-10-13
• Last updated: 2018-05-25

Locations

2 sites across 1 country: United Kingdom