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| Name | Class |
|---|---|
| The Medicines Company | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-PCSSC in subjects with elevated LDL-C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-PCSSC | Active Comparator |
| |
| Sterile Normal Saline (0.9% NaCl) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-PCSSC | Drug | Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of ALN-PCSSC evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation | Part 1 (SAD phase): up to 180 days post dose; Part 2 (MD) phase: up to 180 days post final dose |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetics (PK) of ALN-PCSSC (Cmax, tmax, AUC, t1/2) | Part 1 (SAD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 42, 56 days post-dose; Part 2 (MD) phase: predose, 0.5,1,2,4,6,8,12,24,48,72,96 hours; 7, 14, 21, 28, 29, 35, 42, 56, 84 days post-dose | |
| The effect of ALN-PCSSC on serum levels of LDL-C |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Kauffman, MD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Leeds | United Kingdom | ||||
| Richmond Pharmacology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27959715 | Derived | Fitzgerald K, White S, Borodovsky A, Bettencourt BR, Strahs A, Clausen V, Wijngaard P, Horton JD, Taubel J, Brooks A, Fernando C, Kauffman RS, Kallend D, Vaishnaw A, Simon A. A Highly Durable RNAi Therapeutic Inhibitor of PCSK9. N Engl J Med. 2017 Jan 5;376(1):41-51. doi: 10.1056/NEJMoa1609243. Epub 2016 Nov 13. |
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| Sterile Normal Saline (0.9% NaCl) |
| Drug |
calculated volume to match active comparator |
|
| Through the sooner of final follow up visit or 180 days post final dose |
| The effect of ALN-PCSSC on plasma levels of PCSK9 | Through the sooner of final follow up visit or 180 days post final dose |
| London |
| United Kingdom |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C585830 | ALN-PCS |
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