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

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ClinicalTrials.gov Identifier: NCT03309358
Recruitment Status : Terminated (Successful completion of Part A. Company decision to end early.)
First Posted : October 13, 2017
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Synspira, Inc.

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.

Condition or disease Intervention/treatment Phase
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 Drug: Inhaled SNSP113 Drug: Inhaled Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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).
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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.




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309358


Locations
United Kingdom
Royal Brompton Hospital
London, England, United Kingdom, SW3 6NP
Celerion
Belfast, Northern Ireland, United Kingdom, BT9 6AD
Sponsors and Collaborators
Synspira, Inc.
Investigators
Study Director: Maria Theresa Basco, MD, MPH Synspira, Inc.

Responsible Party: Synspira, Inc.
ClinicalTrials.gov Identifier: NCT03309358     History of Changes
Other Study ID Numbers: SNSP113-17-101
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Synspira, Inc.:
Cystic Fibrosis
Pulmonary exacerbation
Pulmonary inflammation
Respiratory tract disease
Pulmonary disease
Biofilms

Additional relevant MeSH terms:
Infection
Communicable Diseases
Fibrosis
Inflammation
Lung Diseases
Cystic Fibrosis
Mycobacterium Infections
Respiratory Tract Diseases
Pneumonia
Pulmonary Fibrosis
Burkholderia Infections
Mycobacterium Infections, Nontuberculous
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Gram-Negative Bacterial Infections