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History of Changes for Study: NCT03309358
A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Latest version (submitted May 23, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 12, 2017 None (earliest Version on record)
2 May 23, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03309358
Submitted Date:  October 12, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: SNSP113-17-101
Brief Title: A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Official Title: 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)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2017
Overall Status: Recruiting
Study Start: September 28, 2017
Primary Completion: June 1, 2018 [Anticipated]
Study Completion: July 1, 2018 [Anticipated]
First Submitted: October 5, 2017
First Submitted that
Met QC Criteria:
October 12, 2017
First Posted: October 13, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
October 12, 2017
Last Update Posted: October 13, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Synspira, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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:
Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
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).
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 41 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of adverse events
[ Time Frame: 8 days ]

To determine the incidence of treatment related adverse events.
2. Spirometry
[ Time Frame: 8 days ]

To assess change from baseline spirometry.
3. Pulse Oximetry
[ Time Frame: 8 days ]

To assess change in baseline pulse oximetry
Secondary Outcome Measures:
1. Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
[ Time Frame: Days 1, 2 and 8 ]

To characterize the pharmacokinetics of SNSP113
2. Area under concentration-time curve from time zero extrapolated to infinity (AUC)
[ Time Frame: Days 1, 2 and 8 ]

To characterize the pharmacokinetics of SNSP113
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based: Yes

Healthy Male Subjects, Part A

Female and Male Subjects with Stable Cystic Fibrosis, Part B

Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Recruiting Manager
Telephone: 02890 554000 (UK)
Email: paula.quinn@celerion.com
Study Officials: Maria Theresa Basco, MD, MPH
Study Director
Synspira, Inc.
Locations: United Kingdom, England
Royal Brompton Hospital
[Recruiting]
London, England, United Kingdom, SW3 6NP
Contact:Contact: Valentina Picano +44 (0) 7703 808 031 valentinapicano@celerion.com
Contact:Principal Investigator: Stuart Elborn, MD, FRCP
United Kingdom, Northern Ireland
Celerion
[Recruiting]
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Contact:Contact: Fiona McNeilly +44 (0) 2890554001 Fiona.mcneilly@celerion.com
Contact:Principal Investigator: Adrian Stewart, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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