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

Sponsor

Synspira, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03309358

Collaborator

(none)

Enrollment

Locations

Arms

2.7

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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).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 :

Sep 28, 2017

Actual Primary Completion Date :

Dec 18, 2017

Actual Study Completion Date :

Dec 18, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of adverse events [8 days]
To determine the incidence of treatment related adverse events.
Spirometry [8 days]
To assess change from baseline spirometry.
Pulse Oximetry [8 days]
To assess change in baseline pulse oximetry

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.