NCT03146416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started May 2017

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 16, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

May 7, 2017

Last Update Submit

June 21, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment Emergent Adverse Events (TEAEs)

    Baseline up to week 31

  • Severity of TEAEs

    Baseline up to week 31

Secondary Outcomes (29)

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

    Up to Week 31

  • 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

  • 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

  • Ratio of Japanese versus Caucasian populations for geometric means of Cmax

    Up to Week 31

  • Ratio of Japanese versus Caucasian populations for geometric means of AUClast

    Up to Week 31

  • +24 more secondary outcomes

Study Arms (5)

Cohort 1

EXPERIMENTAL

Evinacumab SC or placebo SC

Drug: EvinacumabDrug: Placebo

Cohort 2

EXPERIMENTAL

Low dose regimen: evinacumab IV or placebo IV

Drug: EvinacumabDrug: Placebo

Cohort 3

EXPERIMENTAL

High dose regimen: evinacumab IV or placebo IV

Drug: EvinacumabDrug: Placebo

Cohort 4

EXPERIMENTAL

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

Drug: EvinacumabDrug: Placebo

Cohort 5

EXPERIMENTAL

Evinacumab or placebo SC x 1 dose

Drug: EvinacumabDrug: Placebo

Interventions

EvinacumabDRUG

SC or IV administration of Evinacumab

Also known as: REGN1500
Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5
PlaceboDRUG

Matching placebo

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

Related Publications (1)

  • Harada-Shiba M, Ali S, Gipe DA, Gasparino E, Son V, Zhang Y, Pordy R, Catapano AL. A randomized study investigating the safety, tolerability, and pharmacokinetics of evinacumab, an ANGPTL3 inhibitor, in healthy Japanese and Caucasian subjects. Atherosclerosis. 2020 Dec;314:33-40. doi: 10.1016/j.atherosclerosis.2020.10.013. Epub 2020 Oct 10.

    PMID: 33130482DERIVED

MeSH Terms

Interventions

evinacumab

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2017

First Posted

May 10, 2017

Study Start

May 16, 2017

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Locations

US(1)