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