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This is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. Safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be drawn at specified timepoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo comparator |
|
| QCC374 | Experimental | Single and multiple ascending doses of QCC374 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QCC374 | Drug | Single and multiple ascending doses of QCC374 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Number of Participants with Adverse Events | 39 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf | Area under the plasma concentration-time curve from time zero to infinity | 39 days |
| AUClast | The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Mid Glamorgan | Wales | CF484DR | United Kingdom |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
Placebo comparator |
|
| 39 days |
| AUCtau | The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau | 39 days |
| Cav | The average steady state plasma concentration during multiple dosing | 39 days |
| Cmax | The observed maximum plasma concentration following drug administration | 39 days |
| T1/2 | The terminal elimination half life | 39 days |
| Tmax | The time to reach the maximum concentration after drug administration | 39 days |