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Injection Site Tolerability, Safety, Pharmacokinetics and Pharmacodynamics Study After a Single Dose Subcutaneous Treatment of Alirocumab SAR236553 (REGN727)

NCT ID: NCT01448239

Last Updated: 2013-06-28

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-05-31

Brief Summary

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Primary Objective:

Injection Site Tolerability

Secondary Objectives:

* To assess the safety profile of alirocumab SAR236553 (REGN727)
* To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)

Detailed Description

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The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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alirocumab SAR236553 (REGN727) - Dose A

A single subcutaneous injection of Dose A

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

alirocumab SAR236553 (REGN727) - Dose B

A single subcutaneous injection of Dose B

Group Type EXPERIMENTAL

alirocumab SAR236553 (REGN727)

Intervention Type DRUG

Pharmaceutical form:Solution Route of administration: Subcutaneous

Interventions

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alirocumab SAR236553 (REGN727)

Pharmaceutical form:Solution Route of administration: Subcutaneous

Intervention Type DRUG

alirocumab SAR236553 (REGN727)

Pharmaceutical form:Solution Route of administration: Subcutaneous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Serum troponin I level should not exceed the upper laboratory limit of normal.
* Male or female subject, between 18 and 65 years inclusive.
* Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.
* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Normal vital signs after 10 minutes resting in supine position.
* Normal standard 12-lead ECG after 10 minutes resting in supine position.
* Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects
* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.
* Serum LDL-C levels\>100 mg/dL at screening visit.

Exclusion Criteria

* Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).
* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). Subjects must be willing to maintain a consistent diet for the duration of the study.
* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.
* Fasting serum triglycerides \>200 mg/dL measured after an 8 to 12 hour fast.
* History of a hypersensitivity reaction to doxycycline or similar compound.

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

65 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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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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U1111-1118-2935

Identifier Type: OTHER

Identifier Source: secondary_id

PKD12010

Identifier Type: -

Identifier Source: org_study_id