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)

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 Overview

• Status: Terminated
• Conditions: Lung Diseases; Cystic Fibrosis; Pulmonary Disease; Antibiotic Resistant Infection; Respiratory Tract Disease; Cystic Fibrosis Pulmonary Exacerbation; Lung Inflammation; Burkholderia Infections; Lung Infection; Multi-antibiotic Resistance; Pulmonary Inflammation; Lung Infection Pseudomonal; Cystic Fibrosis Lung; Cystic Fibrosis With Exacerbation; Lung; Infection, Atypical Mycobacterium; Burkholderia Cepacia Infection
• Intervention / Treatment: Drug: Inhaled SNSP113; Drug: Inhaled Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, SW3 6NP
      • Royal Brompton Hospital
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT9 6AD
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Inhaled Placebo	Drug: Inhaled Placebo; A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
Experimental: Inhaled SNSP113	Drug: Inhaled SNSP113; A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)	To characterize the pharmacokinetics of SNSP113	Days 1, 2 and 8
Area under concentration-time curve from time zero extrapolated to infinity (AUC)	To characterize the pharmacokinetics of SNSP113	Days 1, 2 and 8

Collaborators and Investigators

• Sponsor: Synspira, Inc.
• Investigators: Study Director: Maria Theresa Basco, MD, MPH, Synspira, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2017
• Primary Completion (Actual): December 18, 2017
• Study Completion (Actual): December 18, 2017

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2018
• Last Update Submitted That Met QC Criteria: May 23, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Pulmonary exacerbation; Pulmonary disease; Respiratory tract disease; Biofilms; Pulmonary inflammation
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Infections; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Pancreatic Diseases; Fibrosis; Lung Diseases; Inflammation; Infections; Communicable Diseases; Pneumonia; Pulmonary Fibrosis; Cystic Fibrosis; Respiratory Tract Diseases; Mycobacterium Infections, Nontuberculous; Burkholderia Infections
• Other Study ID Numbers: SNSP113-17-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No