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The primary objective of the study is to compare the safety and tolerability of subcutaneous (SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Evinacumab SC or placebo SC |
|
| Cohort 2 | Experimental | Low dose regimen: evinacumab IV or placebo IV |
|
| Cohort 3 | Experimental | High dose regimen: evinacumab IV or placebo IV |
|
| Cohort 4 | Experimental | Evinacumab or placebo SC every week (QW) x 8 doses |
|
| Cohort 5 | Experimental | Evinacumab or placebo SC x 1 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evinacumab | Drug | SC or IV administration of Evinacumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Baseline up to week 31 | |
| Severity of TEAEs | Baseline up to week 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax) | Up to Week 31 | |
| PK parameters of evinacumab for geometric means of Area under the curve (AUC) computed from time zero to the last measurable concentration (AUClast) |
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Key Inclusion Criteria:
Healthy male or female Japanese and Caucasian volunteers ≥18 and ≤55 years of age at the screening visit.
Japanese subjects must:
Caucasian subjects must be Caucasian of European or Latin American descent
Modest elevations in LDL-C (≥100 mg/dL, but <160 mg/dL)
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, Inc. | Cypress | California | 90630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33130482 | Derived | Harada-Shiba M, Ali S, Gipe DA, Gasparino E, Son V, Zhang Y, Pordy R, Catapano AL. A randomized study investigating the safety, tolerability, and pharmacokinetics of evinacumab, an ANGPTL3 inhibitor, in healthy Japanese and Caucasian subjects. Atherosclerosis. 2020 Dec;314:33-40. doi: 10.1016/j.atherosclerosis.2020.10.013. Epub 2020 Oct 10. |
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| ID | Term |
|---|---|
| C000621590 | evinacumab |
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| Placebo | Drug | Matching placebo |
|
single dose cohort
| Up to Week 31 |
| PK parameters of evinacumab for geometric means of AUC computed from time zero to the end of a dosing interval (AUCtau) | following the first dose for the multiple dose cohorts | Up to Week 31 |
| Ratio of Japanese versus Caucasian populations for geometric means of Cmax | Up to Week 31 |
| Ratio of Japanese versus Caucasian populations for geometric means of AUClast | single dose cohort | Up to Week 31 |
| Ratio of Japanese versus Caucasian populations for geometric means of AUCtau | following the first dose for the multiple dose cohorts | Up to Week 31 |
| Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C) | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: Total cholesterol | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C) | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: Triglycerides | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: non-HDL-C | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)] | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB] | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1] | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3] | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP] | Up to Week 31 |
| Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3) | Up to Week 31 |
| Percent change from baseline over time in the PD variable: LDL-C | Up to Week 31 |
| Percent change from baseline over time in the PD variable: Total cholesterol | Up to Week 31 |
| Percent change from baseline over time in the PD variable: HDL-C | Up to Week 31 |
| Percent change from baseline over time in the PD variable: Triglycerides | Up to Week 31 |
| Percent change from baseline over time in the PD variable: non-HDL-C | Up to Week 31 |
| Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)] | Up to Week 31 |
| Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB] | Up to Week 31 |
| Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1] | Up to Week 31 |
| Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3] | Up to Week 31 |
| Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP] | Up to Week 31 |
| Percent change from baseline over time in the PD variable: Total (ANGPTL3) | Up to Week 31 |
| Presence and titer of anti-evinacumab antibodies | Up to Week 31 |