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

NCT03309358 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-05-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Synspira, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Theresa Basco, MD, MPH · Synspira, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2017-12-18
Completion
2017-12-18

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03309358 on ClinicalTrials.gov