Clinical trial NCT03309358: 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
Overall status: TERMINATED
Phase: PHASE1
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
Lead sponsor: Synspira, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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).
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 8 days
measure: Spirometry
timeFrame: 8 days
measure: Pulse Oximetry
timeFrame: 8 days
Secondary outcomes:
measure: Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)
timeFrame: Days 1, 2 and 8
measure: Area under concentration-time curve from time zero extrapolated to infinity (AUC)
timeFrame: Days 1, 2 and 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
state: England
city: Belfast
country: United Kingdom
facility: Celerion
state: Northern Ireland
Study officials:
affiliation: Synspira, Inc.
name: Maria Theresa Basco, MD, MPH
role: STUDY_DIRECTOR
References: