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

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT03146416
Collaborator
(none)
96
Enrollment
1
Location
5
Arms
12.9
Actual Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Evinacumab in Healthy Japanese and Caucasian Subjects
Actual Study Start Date :
May 16, 2017
Actual Primary Completion Date :
Jun 14, 2018
Actual Study Completion Date :
Jun 14, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Evinacumab SC or placebo SC

Drug: Evinacumab
SC or IV administration of Evinacumab
Other Names:
  • REGN1500

    • Drug: Placebo
    Matching placebo
    Experimental: Cohort 2

    Low dose regimen: evinacumab IV or placebo IV

    Drug: Evinacumab
    SC or IV administration of Evinacumab
    Other Names:
  • REGN1500

    • Drug: Placebo
    Matching placebo
    Experimental: Cohort 3

    High dose regimen: evinacumab IV or placebo IV

    Drug: Evinacumab
    SC or IV administration of Evinacumab
    Other Names:
  • REGN1500

    • Drug: Placebo
    Matching placebo
    Experimental: Cohort 4

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

    Drug: Evinacumab
    SC or IV administration of Evinacumab
    Other Names:
  • REGN1500

    • Drug: Placebo
    Matching placebo
    Experimental: Cohort 5

    Evinacumab or placebo SC x 1 dose

    Drug: Evinacumab
    SC or IV administration of Evinacumab
    Other Names:
  • REGN1500

    • Drug: Placebo
    Matching placebo

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment Emergent Adverse Events (TEAEs) [Baseline up to week 31]

    2. Severity of TEAEs [Baseline up to week 31]

    Secondary Outcome Measures

    1. Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax) [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) [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) [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 [Up to Week 31]

    5. Ratio of Japanese versus Caucasian populations for geometric means of AUClast [Up to Week 31]

      single dose cohort

    6. Ratio of Japanese versus Caucasian populations for geometric means of AUCtau [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) [Up to Week 31]

    8. Absolute change from baseline over time in the PD variable: Total cholesterol [Up to Week 31]

    9. Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C) [Up to Week 31]

    10. Absolute change from baseline over time in the PD variable: Triglycerides [Up to Week 31]

    11. Absolute change from baseline over time in the PD variable: non-HDL-C [Up to Week 31]

    12. Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)] [Up to Week 31]

    13. Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB] [Up to Week 31]

    14. Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1] [Up to Week 31]

    15. Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3] [Up to Week 31]

    16. Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP] [Up to Week 31]

    17. Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3) [Up to Week 31]

    18. Percent change from baseline over time in the PD variable: LDL-C [Up to Week 31]

    19. Percent change from baseline over time in the PD variable: Total cholesterol [Up to Week 31]

    20. Percent change from baseline over time in the PD variable: HDL-C [Up to Week 31]

    21. Percent change from baseline over time in the PD variable: Triglycerides [Up to Week 31]

    22. Percent change from baseline over time in the PD variable: non-HDL-C [Up to Week 31]

    23. Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)] [Up to Week 31]

    24. Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB] [Up to Week 31]

    25. Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1] [Up to Week 31]

    26. Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3] [Up to Week 31]

    27. Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP] [Up to Week 31]

    28. Percent change from baseline over time in the PD variable: Total (ANGPTL3) [Up to Week 31]

    29. Presence and titer of anti-evinacumab antibodies [Up to Week 31]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WCCT Global, Inc. Cypress California United States 90630

    Sponsors and Collaborators

    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Regeneron Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03146416
    Other Study ID Numbers:
    • R1500-CL-1642
    First Posted:
    May 10, 2017
    Last Update Posted:
    Jun 25, 2018
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Jun 25, 2018