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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: alirocumab SAR236553 (REGN727)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01785329

U1111-1134-2618 (Other Identifier)

BDR13362

2012-005005-40

Details and patient eligibility

About

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).

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

alirocumab SAR236553 (REGN727) - Dose A

Experimental group

Description:

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)

Treatment:

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - Dose B

Experimental group

Description:

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

Treatment:

Drug: alirocumab SAR236553 (REGN727)

alirocumab SAR236553 (REGN727) - Dose C

Experimental group

Description:

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

Treatment:

Drug: alirocumab SAR236553 (REGN727)