Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers
- Registration Number
- NCT03146416
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
-
Healthy male or female Japanese and Caucasian volunteers ≥18 and ≤55 years of age at the screening visit.
-
Japanese subjects must:
- Be first generation Japanese, defined as born in Japan and both biologic parents are ethnic Japanese
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 2 Placebo Low dose regimen: evinacumab IV or placebo IV Cohort 3 Placebo High dose regimen: evinacumab IV or placebo IV Cohort 4 Placebo Evinacumab or placebo SC every week (QW) x 8 doses Cohort 1 Placebo Evinacumab SC or placebo SC Cohort 5 Placebo Evinacumab or placebo SC x 1 dose Cohort 1 Evinacumab Evinacumab SC or placebo SC Cohort 2 Evinacumab Low dose regimen: evinacumab IV or placebo IV Cohort 3 Evinacumab High dose regimen: evinacumab IV or placebo IV Cohort 4 Evinacumab Evinacumab or placebo SC every week (QW) x 8 doses Cohort 5 Evinacumab Evinacumab or placebo SC x 1 dose
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) Baseline up to week 31 Severity of TEAEs Baseline up to week 31
- Secondary Outcome Measures
Name Time Method 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) Up to Week 31 single dose cohort
PK parameters of evinacumab for geometric means of AUC computed from time zero to the end of a dosing interval (AUCtau) Up to Week 31 following the first dose for the multiple dose cohorts
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 Up to Week 31 single dose cohort
Ratio of Japanese versus Caucasian populations for geometric means of AUCtau Up to Week 31 following the first dose for the multiple dose cohorts
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
Trial Locations
- Locations (1)
WCCT Global, Inc.
🇺🇸Cypress, California, United States