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OpenTrials
Completed

NCT Number: NCT03146416

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

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

WCCT Global, Inc.

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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

Treatment and study plan

Evinacumab

Drug

SC or IV administration of Evinacumab

Other names: REGN1500

Placebo

Drug

Matching placebo

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Baseline up to week 31

  2. Severity of TEAEs

    Time frame: Baseline up to week 31

Secondary outcomes

  1. Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax)

    Time frame: Up to Week 31

  2. PK parameters of evinacumab for geometric means of Area under the curve (AUC) computed from time zero to the last measurable concentration (AUClast)

    Time frame: Up to Week 31

    single dose cohort

  3. PK parameters of evinacumab for geometric means of AUC computed from time zero to the end of a dosing interval (AUCtau)

    Time frame: Up to Week 31

    following the first dose for the multiple dose cohorts

  4. Ratio of Japanese versus Caucasian populations for geometric means of Cmax

    Time frame: Up to Week 31

  5. Ratio of Japanese versus Caucasian populations for geometric means of AUClast

    Time frame: Up to Week 31

    single dose cohort

  6. Ratio of Japanese versus Caucasian populations for geometric means of AUCtau

    Time frame: Up to Week 31

    following the first dose for the multiple dose cohorts

  7. Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C)

    Time frame: Up to Week 31

  8. Absolute change from baseline over time in the PD variable: Total cholesterol

    Time frame: Up to Week 31

  9. Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C)

    Time frame: Up to Week 31

  10. Absolute change from baseline over time in the PD variable: Triglycerides

    Time frame: Up to Week 31

  11. Absolute change from baseline over time in the PD variable: non-HDL-C

    Time frame: Up to Week 31

  12. Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)]

    Time frame: Up to Week 31

  13. Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB]

    Time frame: Up to Week 31

  14. Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]

    Time frame: Up to Week 31

  15. Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]

    Time frame: Up to Week 31

  16. Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]

    Time frame: Up to Week 31

  17. Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3)

    Time frame: Up to Week 31

  18. Percent change from baseline over time in the PD variable: LDL-C

    Time frame: Up to Week 31

  19. Percent change from baseline over time in the PD variable: Total cholesterol

    Time frame: Up to Week 31

  20. Percent change from baseline over time in the PD variable: HDL-C

    Time frame: Up to Week 31

  21. Percent change from baseline over time in the PD variable: Triglycerides

    Time frame: Up to Week 31

  22. Percent change from baseline over time in the PD variable: non-HDL-C

    Time frame: Up to Week 31

  23. Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)]

    Time frame: Up to Week 31

  24. Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB]

    Time frame: Up to Week 31

  25. Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]

    Time frame: Up to Week 31

  26. Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]

    Time frame: Up to Week 31

  27. Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]

    Time frame: Up to Week 31

  28. Percent change from baseline over time in the PD variable: Total (ANGPTL3)

    Time frame: Up to Week 31

  29. Presence and titer of anti-evinacumab antibodies

    Time frame: Up to Week 31

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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