Clinical Trials/NCT03146416

NCT03146416

Completed

Phase 1

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

Regeneron Pharmaceuticals1 site in 1 country96 target enrollmentMay 16, 2017

ConditionsHealthy Volunteers

InterventionsPlacebo Evinacumab

DrugsEvinacumab Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteers
Sponsor: Regeneron Pharmaceuticals
Enrollment: 96
Locations: 1
Primary Endpoint: Incidence of Treatment Emergent Adverse Events (TEAEs)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 16, 2017

End Date

June 14, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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)

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

Arms & Interventions

Cohort 2

Low dose regimen: evinacumab IV or placebo IV

Intervention: Placebo

Cohort 1

Evinacumab SC or placebo SC

Intervention: Evinacumab

Cohort 1

Evinacumab SC or placebo SC

Intervention: Placebo

Cohort 2

Low dose regimen: evinacumab IV or placebo IV

Intervention: Evinacumab

Cohort 3

High dose regimen: evinacumab IV or placebo IV

Intervention: Evinacumab

Cohort 3

High dose regimen: evinacumab IV or placebo IV

Intervention: Placebo

Cohort 4

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

Intervention: Evinacumab

Cohort 4

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

Intervention: Placebo

Cohort 5

Evinacumab or placebo SC x 1 dose

Intervention: Evinacumab

Cohort 5

Evinacumab or placebo SC x 1 dose

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Treatment Emergent Adverse Events (TEAEs)

Time Frame: Baseline up to week 31

Severity of TEAEs

Time Frame: Baseline up to week 31

Secondary Outcomes

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)
Ratio of Japanese versus Caucasian populations for geometric means of AUCtau(Up to Week 31)
Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C)(Up to Week 31)
Absolute change from baseline over time in the PD variable: Total cholesterol(Up to Week 31)
Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C)(Up to Week 31)
Absolute change from baseline over time in the PD variable: Triglycerides(Up to Week 31)
Absolute change from baseline over time in the PD variable: non-HDL-C(Up to Week 31)
Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)](Up to Week 31)
Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB](Up to Week 31)
Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1](Up to Week 31)
Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3](Up to Week 31)
Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP](Up to Week 31)
Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3)(Up to Week 31)
Percent change from baseline over time in the PD variable: LDL-C(Up to Week 31)
Percent change from baseline over time in the PD variable: Total cholesterol(Up to Week 31)
Percent change from baseline over time in the PD variable: HDL-C(Up to Week 31)
Percent change from baseline over time in the PD variable: Triglycerides(Up to Week 31)
Percent change from baseline over time in the PD variable: non-HDL-C(Up to Week 31)
Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)](Up to Week 31)
Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB](Up to Week 31)
Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1](Up to Week 31)
Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3](Up to Week 31)
Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP](Up to Week 31)
Percent change from baseline over time in the PD variable: Total (ANGPTL3)(Up to Week 31)
Presence and titer of anti-evinacumab antibodies(Up to Week 31)