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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146416
• Other study ID #: R1500-CL-1642
• Status: Completed
• Phase: Phase 1
• Start date: May 16, 2017
• Est. completion date: June 14, 2018

Study information

• Verified date: June 2018
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 14, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Evinacumab
SC or IV administration of Evinacumab
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	WCCT Global, Inc.	Cypress	California

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Baseline up to week 31
Primary	Severity of TEAEs		Baseline up to week 31
Secondary	Pharmacokinetic (PK) parameters of evinacumab for geometric means of maximum (or peak) serum concentration (Cmax)		Up to Week 31
Secondary	PK parameters of evinacumab for geometric means of Area under the curve (AUC) computed from time zero to the last measurable concentration (AUClast)	single dose cohort	Up to Week 31
Secondary	PK parameters of evinacumab for geometric means of AUC computed from time zero to the end of a dosing interval (AUCtau)	following the first dose for the multiple dose cohorts	Up to Week 31
Secondary	Ratio of Japanese versus Caucasian populations for geometric means of Cmax		Up to Week 31
Secondary	Ratio of Japanese versus Caucasian populations for geometric means of AUClast	single dose cohort	Up to Week 31
Secondary	Ratio of Japanese versus Caucasian populations for geometric means of AUCtau	following the first dose for the multiple dose cohorts	Up to Week 31
Secondary	Absolute change from baseline over time in the Pharmacodynamic (PD) variable: Low-density lipoprotein cholesterol (LDL-C)		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: Total cholesterol		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: High-density lipoprotein cholesterol (HDL-C)		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: Triglycerides		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: non-HDL-C		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: lipoprotein a [Lp(a)]		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: apolipoprotein B [ApoB]		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]		Up to Week 31
Secondary	Absolute change from baseline over time in the PD variable: Total Angiopoietin-like 3 (ANGPTL3)		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: LDL-C		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: Total cholesterol		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: HDL-C		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: Triglycerides		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: non-HDL-C		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: lipoprotein a [Lp(a)]		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: apolipoprotein B [ApoB]		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: apolipoprotein A1 [ApoA1]		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: apolipoprotein C3 [ApoC3]		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: high-sensitivity C-reactive protein [hs-CRP]		Up to Week 31
Secondary	Percent change from baseline over time in the PD variable: Total (ANGPTL3)		Up to Week 31
Secondary	Presence and titer of anti-evinacumab antibodies		Up to Week 31