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

NCT03309358 | Terminated Phase 1

• 1 other identifier: SNSP113-17-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

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

Keywords

Cystic Fibrosis; Pulmonary exacerbation; Pulmonary inflammation; Respiratory tract disease; Pulmonary disease; Biofilms

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  To determine the incidence of treatment related adverse events.

  8 days

• Spirometry

  To assess change from baseline spirometry.

  8 days

• Pulse Oximetry

  To assess change in baseline pulse oximetry

  8 days

Secondary Outcomes (2)

• 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

Study Arms (2)

Inhaled SNSP113

EXPERIMENTAL

Drug: Inhaled SNSP113

Inhaled Placebo

PLACEBO COMPARATOR

Drug: Inhaled Placebo

Interventions

Inhaled SNSP113 DRUG

A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.

Inhaled SNSP113

Inhaled Placebo DRUG

A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.

Inhaled Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Healthy Male Subjects, Part A Female and Male Subjects with Stable Cystic Fibrosis, Part B
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synspira, Inc.: lead

Study Sites (2)

Royal Brompton Hospital

London, England, SW3 6NP, United Kingdom

Location

Celerion

Belfast, Northern Ireland, BT9 6AD, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases; Cystic Fibrosis; Respiratory Tract Diseases; Pneumonia; Infections; Mycobacterium Infections, Nontuberculous; Burkholderia Infections

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiratory Tract Infections; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections

Study Officials

• Maria Theresa Basco, MD, MPH

  Synspira, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multiple-site, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to assess the safety and tolerability of inhaled SNSP113 in healthy subjects (Part A) and subjects with stable CF (Part B).

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 13, 2017
• Study Start: September 28, 2017
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)