Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 6/27/2018 |
| Start Date: | May 16, 2017 |
| End Date: | June 14, 2018 |
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects
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.
(SC) and intravenous (IV) doses of evinacumab in healthy Japanese and Caucasian subjects.
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
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