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Pharmacokinetic of Alirocumab SAR236553 (REGN727) Administered Subcutaneously at 3 Different Injection Sites in Healthy Subjects

NCT ID: NCT01785329

Last Updated: 2013-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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Primary Objective:

To assess the relative bioavailability of a single subcutaneous dose of alirocumab SAR236553 (REGN727) administered at 3 different injection sites in healthy subjects.

Secondary Objectives:

* To assess the pharmacodynamic effect of a single subcutaneous dose of alirocumab SAR236553 (REGN727) on serum low-density lipoprotein cholesterol and other lipids and apolipoproteins.
* To assess the safety of a single subcutaneous dose of alirocumab SAR236553 (REGN727).
* To assess the immunogenicity of a single subcutaneous dose of alirocumab SAR236553 (REGN727).

Detailed Description

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Total duration of the study per subject is about 15 weeks.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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alirocumab SAR236553 (REGN727) - Dose A

alirocumab SAR236553 (REGN727) - Dose A - Injection in healthy subjects through subcutaneous administration in the abdomen.

alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

alirocumab SAR236553 (REGN727) - Dose B

alirocumab SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

alirocumab SAR236553 (REGN727) - Dose C

alirocumab SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Interventions

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alirocumab SAR236553 (REGN727)

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Healthy subjects.

Exclusion Criteria

Healthy subjects with history or presence of clinically relevant illness.

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 826001

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Lunven C, Paehler T, Poitiers F, Brunet A, Rey J, Hanotin C, Sasiela WJ. A randomized study of the relative pharmacokinetics, pharmacodynamics, and safety of alirocumab, a fully human monoclonal antibody to PCSK9, after single subcutaneous administration at three different injection sites in healthy subjects. Cardiovasc Ther. 2014 Dec;32(6):297-301. doi: 10.1111/1755-5922.12093.

Reference Type DERIVED
PMID: 25256660 (View on PubMed)

Other Identifiers

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2012-005005-40

Identifier Type: -

Identifier Source: secondary_id

U1111-1134-2618

Identifier Type: OTHER

Identifier Source: secondary_id

BDR13362

Identifier Type: -

Identifier Source: org_study_id