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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels.
After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Placebo Comparator | LIB003 dose 1 SC |
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| cohort 2 | Placebo Comparator | LIB003 dose 2 SC |
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| cohort 3 | Placebo Comparator | LIB003 dose 4 SC |
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| cohort 4 | Placebo Comparator | LIB003 dose 4 SC |
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| cohort 5 | Placebo Comparator | LIB003 dose 5 SC |
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| cohort 6 | Placebo Comparator | LIB003 dose 4 IV |
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| cohort 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIB003 | Biological | LIB003 or placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of treatment emergent adverse events (TEAEs) | safety and tolerability will be assessed by the incidence and severity of treatment emergent adverse events | 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in serum unbound (free) proprotein convertase subtilisin/kexin type 9 (PCSK9) concentrations over time | Serum free PCSK9 will be measured at baseline and various time points over 43 days | 43 days |
| Absolute change in serum total PCSK9 over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Traci A Turner, MD | Medpace Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medpace (MARC/CPU) | Cincinnati | Ohio | 45227 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2017 | May 22, 2018 | Prot_000.pdf |
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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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single ascending dose with placebo controll
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Within each dosing cohort randomization is performed according to a computer-generated randomization scheme. Other than the study drug prepared by an unblinded pharmacist and administered by unblinded nurses who will be instructed not to discuss randomized treatment assignments and have no other role in the study, all study staff and PI, along with the subjects are blinded as to treatment.
LIB003 dose 5 IV |
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| cohort 8 | Placebo Comparator | LIB003 dose 3 SC - statin treated |
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| cohort 9 | Placebo Comparator | LIB003 dose 4 SC - statin treated |
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Serum total PCSK9 will be measured at baseline and various time points over 43 days |
| 43 days |
| Percent change in Low Density Lipoprotein cholesterol (LDL-C) over time | Serum LDL-C will be measured at baseline and various time points over 43 days to derive percent change | 43 days |
| Percent change in Apolipoprotein B (Apo B) over time | Serum Apo B will be measured at baseline and various time points over 43 days to derive percent change | 43 days |
| Changes in serum LIB003 concentrations over time | serum LIB003 will be measured at various time points to derive AUC (area under curve) | 43 days |
| Presence of anti LIB003 antibodies (ADAs) | Measurement of ADAs will be done at baseline and various intervals after LIB003 administration | 43 days |
| D009750 |
| Nutritional and Metabolic Diseases |