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Successful completion of Part A. Company decision to end early.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled SNSP113 | Experimental |
| |
| Inhaled Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled SNSP113 | Drug | A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | To determine the incidence of treatment related adverse events. | 8 days |
| Spirometry | To assess change from baseline spirometry. | 8 days |
| Pulse Oximetry | To assess change in baseline pulse oximetry | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax) | To characterize the pharmacokinetics of SNSP113 | Days 1, 2 and 8 |
| Area under concentration-time curve from time zero extrapolated to infinity (AUC) |
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Inclusion Criteria:
Part A
Part B
Exclusion Criteria:
Part A
Part B
Healthy Male Subjects, Part A
Female and Male Subjects with Stable Cystic Fibrosis, Part B
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| Name | Affiliation | Role |
|---|---|---|
| Maria Theresa Basco, MD, MPH | Synspira, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | England | SW3 6NP | United Kingdom | ||
| Celerion |
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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).
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| Inhaled Placebo | Drug | A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis. |
|
To characterize the pharmacokinetics of SNSP113 |
| Days 1, 2 and 8 |
| Belfast |
| Northern Ireland |
| BT9 6AD |
| United Kingdom |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D003550 | Cystic Fibrosis |
| D012140 | Respiratory Tract Diseases |
| D011014 | Pneumonia |
| D007239 | Infections |
| D009165 | Mycobacterium Infections, Nontuberculous |
| D019121 | Burkholderia Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D012141 | Respiratory Tract Infections |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D016905 | Gram-Negative Bacterial Infections |
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