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

• Status: Completed
• Trial end date: 2018-06-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Regeneron Pharmaceuticals

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