Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers

Regeneron Pharmaceuticals96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

EvinacumabDRUG

SC or IV administration of Evinacumab

PlaceboDRUG

Matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Healthy male or female Japanese and Caucasian volunteers ≥18 and ≤55 years of age at the screening visit. * Japanese subjects must: 1. Be first generation Japanese, defined as born in Japan and both biologic parents are ethnic Japanese 2. Have maintained a Japanese lifestyle that has not significantly changed since leaving Japan, including having access to Japanese food and adhering to a Japanese diet. * 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: * Significant concomitant illness * Known allergy or sensitivity to monoclonal antibodies (mAbs) * Previous exposure to anti-ANGPTL3 antibody * Body mass index (BMI) \>35 kg/m2 at the screening visit Note: Other protocol-defined inclusion/exclusion criteria apply

Locations (1)

WCCT Global, Inc.

Cypress, California, United States

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events (TEAEs)

Time frame: Baseline up to week 31

Severity of TEAEs

Time frame: Baseline up to week 31

Secondary Outcomes

Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax)

Time frame: 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)

single dose cohort

Time frame: 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

Time frame: Up to Week 31

Ratio of Japanese versus Caucasian populations for geometric means of Cmax

Time frame: Up to Week 31

Ratio of Japanese versus Caucasian populations for geometric means of AUClast

single dose cohort

Time frame: Up to Week 31

Ratio of Japanese versus Caucasian populations for geometric means of AUCtau

following the first dose for the multiple dose cohorts

Time frame: Up to Week 31

Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C)

Data from ClinicalTrials.gov

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Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: Total cholesterol

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C)

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: Triglycerides

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: non-HDL-C

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)]

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB]

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]

Time frame: Up to Week 31

Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3)

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: LDL-C

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: Total cholesterol

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: HDL-C

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: Triglycerides

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: non-HDL-C

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)]

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB]

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]

Time frame: Up to Week 31

Percent change from baseline over time in the PD variable: Total (ANGPTL3)

Time frame: Up to Week 31

Presence and titer of anti-evinacumab antibodies

Time frame: Up to Week 31