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A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

alirocumab SAR236553 (REGN727)

placebo

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Healthy male or female subjects.
Aged 18 to 45 years old.
Low-density lipoprotein cholesterol >100 mg/dL (2.59 mmol/L).

Exclusion criteria:

Subjects with any history or presence of clinically relevant illness.
Serum triglycerides >200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting.
Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. Use of probucol within 8 weeks prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

Investigational Site Number 156001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Alirocumab

Placebo

Arm Description

Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design

Subcutaneous injection of a single dose of matching placebo

Outcomes

Primary Outcome Measures

Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests

Incidence of injection site reactions

Secondary Outcome Measures

Change from baseline in LDL-C

Change from baseline in other lipid parameters

Pharmacokinetics: Assessment of serum concentrations of alirocumab

Pharmacokinetics: Assessment of serum concentrations of PCSK9

Full Information

NCT ID

NCT02979015

First Posted

November 29, 2016

Last Updated

December 4, 2017

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02979015

Brief Title

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered Alirocumab in Chinese Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

November 29, 2016 (undefined)

Primary Completion Date

November 27, 2017 (Actual)

Study Completion Date

November 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To assess the safety and tolerability of ascending single SC doses of alirocumab in Chinese healthy subjects. Secondary Objectives: To assess the pharmacokinetic profile of a single SC dose of alirocumab. To assess the pharmacodynamic effect of a single SC dose of alirocumab on low-density lipoprotein cholesterol (LDL-C) and other lipid parameters. To assess the immunogenicity of a single SC dose of alirocumab.

Detailed Description

Ascending dose design includes 3 dose levels. Tolerance data up to at least 14 days post dosing from at least 6 subjects of the previous cohort will be reviewed before proceeding with a next dose. Total duration of the study per subject is approximately 15 weeks (including screening period).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alirocumab

Arm Type

Experimental

Arm Description

Subcutaneous injection of a single dose of alirocumab, dose level according to ascending dose design

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subcutaneous injection of a single dose of matching placebo

Intervention Type

Drug

Intervention Name(s)

alirocumab SAR236553 (REGN727)

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Incidence of adverse events based on standard and systematic assessment including physical examinations, 12 lead ECGs, vital signs and laboratory tests

Time Frame

Up to 12 weeks

Title

Incidence of injection site reactions

Time Frame

Up to 4 days

Secondary Outcome Measure Information:

Title

Change from baseline in LDL-C

Time Frame

Up to 12 weeks

Title

Change from baseline in other lipid parameters

Time Frame

Up to 12 weeks

Title

Pharmacokinetics: Assessment of serum concentrations of alirocumab

Time Frame

Up to 12 weeks

Title

Pharmacokinetics: Assessment of serum concentrations of PCSK9

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Healthy male or female subjects. Aged 18 to 45 years old. Low-density lipoprotein cholesterol >100 mg/dL (2.59 mmol/L). Exclusion criteria: Subjects with any history or presence of clinically relevant illness. Serum triglycerides >200 mg/dL (2.26 mmol/L) measured after at least 10 hour fasting. Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening, including but not limited to statins, ezetimibe, fibrates, niacin, or bile acid resins. Use of probucol within 8 weeks prior to screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 156001

City

Beijing

ZIP/Postal Code

100191

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

32080823

Citation

Li H, Wei Y, Yang Z, Zhang S, Xu X, Shuai M, Vitse O, Wu Y, Baccara-Dinet MT, Zhang Y, Li J. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study. Am J Cardiovasc Drugs. 2020 Oct;20(5):489-503. doi: 10.1007/s40256-020-00394-1.

Results Reference

derived

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A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Administered Alirocumab in Healthy Chinese Subjects

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