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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2018-06-14

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cohort 1

Evinacumab SC or placebo SC

Group Type EXPERIMENTAL

Evinacumab

Intervention Type DRUG

SC or IV administration of Evinacumab

Placebo

Intervention Type DRUG

Matching placebo

Cohort 2

Low dose regimen: evinacumab IV or placebo IV

Group Type EXPERIMENTAL

Evinacumab

Intervention Type DRUG

SC or IV administration of Evinacumab

Placebo

Intervention Type DRUG

Matching placebo

Cohort 3

High dose regimen: evinacumab IV or placebo IV

Group Type EXPERIMENTAL

Evinacumab

Intervention Type DRUG

SC or IV administration of Evinacumab

Placebo

Intervention Type DRUG

Matching placebo

Cohort 4

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

Group Type EXPERIMENTAL

Evinacumab

Intervention Type DRUG

SC or IV administration of Evinacumab

Placebo

Intervention Type DRUG

Matching placebo

Cohort 5

Evinacumab or placebo SC x 1 dose

Group Type EXPERIMENTAL

Evinacumab

Intervention Type DRUG

SC or IV administration of Evinacumab

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Evinacumab

SC or IV administration of Evinacumab

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Other Intervention Names

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REGN1500

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes