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The primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of CiVi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1 | Experimental | CiVi007 dose 1 |
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| Cohort A2 | Experimental | CiVi007 dose 2 |
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| Cohort A3 | Experimental | CiVi007 dose 3 |
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| Cohort A4 | Experimental | CiVi007 dose 4 |
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| Cohort A5 | Experimental | CiVi007 dose 5 |
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| Combined placebo group | Placebo Comparator | group response from placebo subsets of dosing cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CiVi007 | Drug | cholesterol lowering drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL Cholesterol | % LDL-C reduction | Maximum post dose within 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of CiVi007 | Pharmacokinetic Outcome Measure | 8 weeks |
| PCSK9 level | maximal % reduction in the level of circulating PCSK9 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Bush, MBChB, PhD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Clinic | Leeds | West Yorkshire | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Adaptive design allowing modifications in single and multidose arms
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| Placebo | Other | matching placebo to CiVi007 |
|
| Maximum post dose within 8 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |