A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
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|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
|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|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)|
|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 :||September 28, 2017|
|Actual Primary Completion Date :||December 18, 2017|
|Actual Study Completion Date :||December 18, 2017|
|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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309358
|Royal Brompton Hospital|
|London, England, United Kingdom, SW3 6NP|
|Belfast, Northern Ireland, United Kingdom, BT9 6AD|
|Study Director:||Maria Theresa Basco, MD, MPH||Synspira, Inc.|