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The purpose of this study is to determine: (1) the safety and pharmacokinetics of APL180 administered as a single intravenous infusion in healthy volunteers, and (2) the safety, pharmacokinetics and pharmacodynamics of single and multiple daily intravenous infusions of APL018 in patients with CHD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APL180 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability, pharmacokinetics and effects on biomarkers of HDL function of APL180 after a single and 7-daily infusions in healthy volunteers (HV) and in patients with coronary heart disease (CHD) | throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic/pharmacodynamic relationship after a single and 7 daily infusions in CHD patients | throughout the study |
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Inclusion Criteria:
Exclusion Criteria for both healthy volunteers and patients:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| NOVARTIS | Novartis investigative site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Philadelphia | Pennsylvania | United States | |||
| Novartis Investigator Site |
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| Label | URL |
|---|---|
| Results for CAPL180A2201 from the Novartis Clinical Trials website | View source |
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|
| Antwerp |
| Belgium |
| Novartis Investigator Site | Birkeroed | Denmark |
| Novartis Investigator Site | Jerusalem | Israel |
| Novartis Investigator Site | Tel Aviv | Israel |
| Novartis Investigator Site | Tzrifin | Israel |
| Novartis Investigator Site | Groningen | Netherlands |
| Novartis Investigator Site | Bloemfontein | South Africa |
| Novartis Investigator Site | George | South Africa |
| Novartis Investigator Site | Port Elizabeth | South Africa |
| Novartis Investigator Site | Harrow | United Kingdom |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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