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The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-TTRSC (revusiran) | Active Comparator |
| |
| Sterile Normal Saline (0.9% NaCl) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-TTRSC (revusiran) | Drug | Ascending doses of ALN-TTRSC (revusiran) by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation. | Up to 63 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of ALN-TTRSC (revusiran) (Cmax, tmax, t1/2, AUC0-last, CL). | Up to 90 days | |
| Effect of ALN-TTRSC (revusiran) on transthyretin (TTR) (Determination of % Lowering of TTR to pretreatment/Baseline Levels). | Up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Gollob, MD | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Leeds | LS2 9LH | United Kingdom | |||
| Clinical Site |
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| Sterile Normal Saline (0.9% NaCl) | Drug | Calculated volume to match active comparator |
|
| Effect of ALN-TTRSC (revusiran) on vitamin A (Determination of % Lowering of vitamin A to pretreatment/Baseline Levels). | Up to 90 days |
| Effect of ALN-TTRSC (revusiran) on retinol binding protein (RBP) (Determination of % Lowering of RBP to pretreatment/Baseline Levels). | Up to 90 days |
| London |
| NW10 7EW |
| United Kingdom |
| ID | Term |
|---|---|
| C000614277 | revusiran |
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