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

Primary Purpose

Lung Diseases, Pulmonary Disease, Cystic Fibrosis

Status

Terminated

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Inhaled SNSP113

Inhaled Placebo

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Cystic Fibrosis, Pulmonary exacerbation, Pulmonary inflammation, Respiratory tract disease, Pulmonary disease, Biofilms

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Royal Brompton Hospital
Celerion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled SNSP113

Inhaled Placebo

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events

To determine the incidence of treatment related adverse events.

Spirometry

To assess change from baseline spirometry.

Pulse Oximetry

To assess change in baseline pulse oximetry

Secondary Outcome Measures

Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)

To characterize the pharmacokinetics of SNSP113

Area under concentration-time curve from time zero extrapolated to infinity (AUC)

To characterize the pharmacokinetics of SNSP113

Full Information

NCT ID

NCT03309358

First Posted

October 5, 2017

Last Updated

May 23, 2018

Sponsor

Synspira, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03309358

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Terminated

Why Stopped

Successful completion of Part A. Company decision to end early.

Study Start Date

September 28, 2017 (Actual)

Primary Completion Date

December 18, 2017 (Actual)

Study Completion Date

December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Synspira, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

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

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled SNSP113

Arm Type

Experimental

Arm Title

Inhaled Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Inhaled SNSP113

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Inhaled Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events

Description

To determine the incidence of treatment related adverse events.

Time Frame

8 days

Title

Spirometry

Description

To assess change from baseline spirometry.

Time Frame

8 days

Title

Pulse Oximetry

Description

To assess change in baseline pulse oximetry

Time Frame

8 days

Secondary Outcome Measure Information:

Title

Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)

Description

To characterize the pharmacokinetics of SNSP113

Time Frame

Days 1, 2 and 8

Title

Area under concentration-time curve from time zero extrapolated to infinity (AUC)

Description

To characterize the pharmacokinetics of SNSP113

Time Frame

Days 1, 2 and 8

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Healthy Male Subjects, Part A Female and Male Subjects with Stable Cystic Fibrosis, Part B

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Theresa Basco, MD, MPH

Organizational Affiliation

Synspira, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Royal Brompton Hospital

City

London

State/Province

England

ZIP/Postal Code

SW3 6NP

Country

United Kingdom

Facility Name

Celerion

City

Belfast

State/Province

Northern Ireland

ZIP/Postal Code

BT9 6AD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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