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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Evinacumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03146416

R1500-CL-1642

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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96 participants in 5 patient groups

Cohort 1

Experimental group

Description:

Evinacumab SC or placebo SC

Treatment:

Drug: Evinacumab

Drug: Placebo

Cohort 2

Experimental group

Description:

Low dose regimen: evinacumab IV or placebo IV

Treatment:

Drug: Evinacumab

Drug: Placebo

Cohort 3

Experimental group

Description:

High dose regimen: evinacumab IV or placebo IV

Treatment:

Drug: Evinacumab

Drug: Placebo

Cohort 4

Experimental group

Description:

Evinacumab or placebo SC every week (QW) x 8 doses

Treatment:

Drug: Evinacumab

Drug: Placebo

Cohort 5

Experimental group

Description:

Evinacumab or placebo SC x 1 dose

Treatment:

Drug: Evinacumab

Drug: Placebo