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Study was redesigned based on FDA feedback.
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The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| RN316: 1 mg/kg every 2 weeks | Experimental |
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| RN316: 2 mg/kg every 4 weeks | Experimental |
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| RN316: 4 mg/kg every 4 weeks | Experimental |
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| RN316: 4 mg/kg every 8 weeks | Experimental |
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| RN316: 8 mg/kg every 8 weeks | Experimental |
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| RN316: 12 mg/kg every 8 weeks | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting or intolerable treatment related adverse events (AEs). | Every Scheduled Visit | |
| Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). | Every Scheduled Visit | |
| Incidence of abnormal and clinically relevant safety laboratories. | Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197 | |
| Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. | Every Scheduled Visit | |
| Incidence of anti-drug-antibodies. | Baseline and Day 15 and monthly thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316. | Day 1 and every scheduled visit thereafter | |
| Absolute and percentage change in LDL C from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 1 mg/kg every 2 weeks | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
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| 2 mg/kg every 4 weeks | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
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| 4 mg/kg every 4 weeks | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
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| 4 mg/kg every 8 weeks | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
|
| 8 mg/kg every 8 weeks | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
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| 12 mg/kg every 8 weeks | Biological | Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight. |
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| Every scheduled visit except Day 1 |
| Proportion of subjects who achieve a target LDL C of <100 mg/mL. | Every scheduled visit except Day 1 |
| Proportion of subjects who achieve a target LDL C of <70 mg/dL. | Every scheduled visit except Day 1 |
| Proportion of subjects achieving 50% decrease in LDL C from baseline. | Every scheduled visit except Day 1 |