Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    SNSP113
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE October 5, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date May 25, 2018
Actual Study Start Date  ICMJE September 28, 2017
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • Incidence of adverse events [ Time Frame: 8 days ]
    To determine the incidence of treatment related adverse events.
  • Spirometry [ Time Frame: 8 days ]
    To assess change from baseline spirometry.
  • Pulse Oximetry [ Time Frame: 8 days ]
    To assess change in baseline pulse oximetry
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03309358 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
Official Title  ICMJE 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)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Inhaled SNSP113
    Intervention: Drug: Inhaled SNSP113
  • Placebo Comparator: Inhaled Placebo
    Intervention: Drug: Inhaled Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 23, 2018)
32
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
41
Actual Study Completion Date  ICMJE December 18, 2017
Actual Primary Completion Date December 18, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
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

Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309358
Other Study ID Numbers  ICMJE SNSP113-17-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Synspira, Inc.
Study Sponsor  ICMJE Synspira, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maria Theresa Basco, MD, MPH Synspira, Inc.
PRS Account Synspira, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP