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Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Alirocumab (Solution)

Alirocumab (Lyophilized formulation)

Placebo (Solution)

Placebo (Lyophilized formulation)

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male subject, between 20 and 65 years inclusive.
Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
Serum LDL-C levels >100 mg/dL

Exclusion Criteria:

Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
History or presence of drug or alcohol abuse
Smoking more than 5 cigarettes or equivalent in any 24 hour period.
Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
Presence or history of drug hypersensitivity
Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
Initiation of a new diet or major change to a previous diet within 4 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

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Alirocumab dose 1 versus placebo

Alirocumab dose 2 versus placebo

Alirocumab dose 3 versus placebo

Alirocumab dose 4 versus placebo

Outcomes

Primary Outcome Measures

Number of participants with Adverse Events

Secondary Outcome Measures

Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.

Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.

Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit.

Full Information

NCT ID

NCT01448317

First Posted

September 21, 2011

Last Updated

September 27, 2016

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01448317

Brief Title

Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (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 doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects. Secondary Objectives: To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a). To assess the Pharmacokinetic profile of a single SC dose of alirocumab. To assess the immunogenicity of a single SC dose of alirocumab.

Detailed Description

4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.

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

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Alirocumab dose 1 versus placebo

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Alirocumab dose 2 versus placebo

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

Alirocumab dose 3 versus placebo

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

Alirocumab dose 4 versus placebo

Intervention Type

Drug

Intervention Name(s)

Alirocumab (Solution)

Other Intervention Name(s)

SAR236553, REGN727

Intervention Description

Pharmaceutical form: solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Alirocumab (Lyophilized formulation)

Other Intervention Name(s)

SAR236553, REGN727

Intervention Description

Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo (Solution)

Intervention Description

Pharmaceutical form: solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

Placebo (Lyophilized formulation)

Intervention Description

Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Number of participants with Adverse Events

Time Frame

106 days

Secondary Outcome Measure Information:

Title

Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit.

Time Frame

106 days

Title

Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit.

Time Frame

106 days

Title

Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit.

Time Frame

106 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male subject, between 20 and 65 years inclusive. Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive. Serum LDL-C levels >100 mg/dL Exclusion Criteria: Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004 Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study. History or presence of drug or alcohol abuse Smoking more than 5 cigarettes or equivalent in any 24 hour period. Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days. Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis. Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol. Presence or history of drug hypersensitivity Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening. Initiation of a new diet or major change to a previous diet within 4 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

Sanofi-Aventis Administrative Office

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

27184170

Citation

Teramoto T, Kobayashi M, Uno K, Takagi Y, Matsuoka O, Sugimoto M, Inoue S, Minami F, Baccara-Dinet MT. Efficacy and Safety of Alirocumab in Japanese Subjects (Phase 1 and 2 Studies). Am J Cardiol. 2016 Jul 1;118(1):56-63. doi: 10.1016/j.amjcard.2016.04.011. Epub 2016 Apr 21.

Results Reference

result

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Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

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