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

Cystic Fibrosis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03309358
• Other study ID #: SNSP113-17-101
• Status: Terminated
• Phase: Phase 1
• Start date: September 28, 2017
• Est. completion date: December 18, 2017

Study information

• Verified date: May 2018
• Source: Synspira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Burkholderia Cepacia Infection
• Burkholderia Infections
• Communicable Diseases
• Cystic Fibrosis
• Cystic Fibrosis Lung
• Cystic Fibrosis Pulmonary Exacerbation
• Cystic Fibrosis With Exacerbation
• Fibrosis
• Infection
• Inflammation
• Lung Diseases
• Lung Infection
• Lung Infection Pseudomonal
• Lung Inflammation
• Lung; Infection, Atypical Mycobacterium
• Multi-antibiotic Resistance
• Mycobacterium Infections
• Mycobacterium Infections, Nontuberculous
• Pneumonia
• Pulmonary Disease
• Pulmonary Fibrosis
• Pulmonary Inflammation
• Respiratory Tract Disease
• Respiratory Tract Diseases

Intervention

Drug:
• Inhaled SNSP113
A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
• Inhaled Placebo
A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.

Locations

Country	Name	City	State
United Kingdom	Celerion	Belfast	Northern Ireland
United Kingdom	Royal Brompton Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Synspira, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	To determine the incidence of treatment related adverse events.	8 days
Primary	Spirometry	To assess change from baseline spirometry.	8 days
Primary	Pulse Oximetry	To assess change in baseline pulse oximetry	8 days
Secondary	Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax)	To characterize the pharmacokinetics of SNSP113	Days 1, 2 and 8
Secondary	Area under concentration-time curve from time zero extrapolated to infinity (AUC)	To characterize the pharmacokinetics of SNSP113	Days 1, 2 and 8