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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03309358
Other study ID # SNSP113-17-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
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
Health authority
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.


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Study Design


Related Conditions & MeSH terms

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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
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