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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

alirocumab SAR236553 (REGN727)

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

alirocumab SAR236553 (REGN727) - Dose A

alirocumab SAR236553 (REGN727) - Dose B

Arm Description

A single subcutaneous injection of Dose A

A single subcutaneous injection of Dose B

Outcomes

Primary Outcome Measures

Pain using present pain intensity (PPI) verbal questionnaire

Erythema at injection site by measuring diameter and qualitative assessment

Edema at injection site by measuring diameter and qualitative assessment

Secondary Outcome Measures

Assessment of PK parameter - time to maximum concentration (tmax)

Assessment of PK parameter - maximum concentration (Cmax)

Assessment of PK parameter - area under curve (AUC)

Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)

Assessment of PK parameter - terminal elimination half-life (t1/2z)

Pharmacodynamics: Change in LDL-C from baseline

Number of participants with Adverse Events

Full Information

NCT ID

NCT01448239

First Posted

October 5, 2011

Last Updated

June 27, 2013

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01448239

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (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: 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

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

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

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

alirocumab SAR236553 (REGN727) - Dose A

Arm Type

Experimental

Arm Description

A single subcutaneous injection of Dose A

Arm Title

alirocumab SAR236553 (REGN727) - Dose B

Arm Type

Experimental

Arm Description

A single subcutaneous injection of Dose B

Intervention Type

Drug

Intervention Name(s)

alirocumab SAR236553 (REGN727)

Intervention Description

Pharmaceutical form:Solution Route of administration: Subcutaneous

Intervention Type

Drug

Intervention Name(s)

alirocumab SAR236553 (REGN727)

Intervention Description

Pharmaceutical form:Solution Route of administration: Subcutaneous

Primary Outcome Measure Information:

Title

Pain using present pain intensity (PPI) verbal questionnaire

Time Frame

6 weeks

Title

Erythema at injection site by measuring diameter and qualitative assessment

Time Frame

6 weeks

Title

Edema at injection site by measuring diameter and qualitative assessment

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Assessment of PK parameter - time to maximum concentration (tmax)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - maximum concentration (Cmax)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - area under curve (AUC)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)

Time Frame

Up to 12 weeks

Title

Assessment of PK parameter - terminal elimination half-life (t1/2z)

Time Frame

Up to 12 weeks

Title

Pharmacodynamics: Change in LDL-C from baseline

Time Frame

Up to 12 weeks

Title

Number of participants with Adverse Events

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Bridgewater

State/Province

New Jersey

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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