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

This study is currently recruiting participants.

Verified March 2013 by Sanofi

Sponsor:

Collaborator:

Regeneron Pharmaceuticals

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01785329

First received: January 30, 2013

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 30, 2013

Last Updated Date

March 11, 2013

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assessment of the serum concentrations of SAR236553 (REGN727) after a single subcutaneous administration at 3 different injection sites in healthy subjects as a measure of the pharmacokinetics of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01785329 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessment of the serum concentrations of low-density lipoprotein cholesterol after a single subcutaneous administration of SAR236553 (REGN727) as a measure of the pharmacodynamic effect of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
Assessment of the number of subjects with adverse events after a single subcutaneous administration of SAR236553 (REGN727) as a measure of the safety/tolerability of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]
Assessment of the serum concentration of anti-drug antibodies after a single subcutaneous dose of SAR236553 (REGN727) as a measure of the immunogenicity of this investigational medicinal product. [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized Study of the Relative Bioavailability, Pharmacodynamics, Safety of SAR236553 (REGN727) After Single Subcutaneous Administration at 3 Different Injection Sites in Healthy Subjects

Brief Summary

Primary Objective:

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

Secondary Objectives:

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Drug: SAR236553 (REGN727)

Pharmaceutical form:Solution for injection Route of administration: Subcutaneous

Study Arm (s)

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

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

Intervention: Drug: SAR236553 (REGN727)
Experimental: SAR236553 (REGN727) - Dose B
SAR236553 (REGN727) - Dose B - Injection in healthy subjects through subcutaneous administration in the upper arm.

Intervention: Drug: SAR236553 (REGN727)
Experimental: SAR236553 (REGN727) - Dose C
SAR236553 (REGN727) - Dose C - Injection in healthy subjects through subcutaneous administration in the thigh.

Intervention: Drug: SAR236553 (REGN727)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: For site information, send an email with site number to

Contact-Us@sanofi.com

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01785329

Other Study ID Numbers ^ICMJE

BDR13362, 2012-005005-40, U1111-1134-2618

Has Data Monitoring Committee

Responsible Party

Sanofi

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Regeneron Pharmaceuticals

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

Information Provided By

Sanofi

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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