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Ascending Dose Study of the Safety and Tolerability of Alirocumab (SAR236553/REGN727) in Japanese Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01448317
First received: September 21, 2011
Last updated: September 27, 2016
Last verified: September 2016
  Purpose

Primary Objective:

To assess the safety and tolerability of ascending single doses of subcutaneously (SC) administered alirocumab (SAR236553/REGN727) in Japanese healthy male subjects.

Secondary Objectives:

  • To assess the pharmacodynamics effect of a single SC dose of alirocumab on serum low-density lipoprotein cholesterol (LDL-C) and other lipids and apolipoproteins such as total cholesterol, high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol, very low-density lipoprotein cholesterol, Triglycerides, Apolipoprotein B, Apolipoprotein A1 and Lipoprotein(a).
  • To assess the Pharmacokinetic profile of a single SC dose of alirocumab.
  • To assess the immunogenicity of a single SC dose of alirocumab.

Condition Intervention Phase
Hypercholesterolemia
Drug: Alirocumab (Solution)
Drug: Alirocumab (Lyophilized formulation)
Drug: Placebo (Solution)
Drug: Placebo (Lyophilized formulation)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered SAR236553 in Japanese Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: 106 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in serum Low-Density Lipoprotein Cholesterol (LDL-C) from baseline to each visit. [ Time Frame: 106 days ] [ Designated as safety issue: No ]
  • Change in ApolipoproteinB, ApolipoproteinA1 and Lipoprotein(a) from baseline to each visit. [ Time Frame: 106 days ] [ Designated as safety issue: No ]
  • Change in Total Cholesterol (T-C), High-Density Lipoprotein Cholesterol (HDL-C), Very Low-Density Lipoprotein Cholesterol (VLDL-C) and Triglycerides (TG) from baseline to each visit. [ Time Frame: 106 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: May 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Alirocumab dose 1 versus placebo
Drug: Alirocumab (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Placebo (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation

Route of administration: Subcutaneous

Experimental: Cohort 2
Alirocumab dose 2 versus placebo
Drug: Alirocumab (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Placebo (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation

Route of administration: Subcutaneous

Experimental: Cohort 3
Alirocumab dose 3 versus placebo
Drug: Alirocumab (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Placebo (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation

Route of administration: Subcutaneous

Experimental: Cohort 4
Alirocumab dose 4 versus placebo
Drug: Alirocumab (Solution)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Drug: Placebo (Solution)

Pharmaceutical form: solution

Route of administration: subcutaneous


Detailed Description:
4 sequential dose cohorts. Single dose followed by a total observation period of 15 weeks (106 days) for each participant.
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subject, between 20 and 65 years inclusive.
  • Body weight between 50.0 and 95.0 kg inclusive, body mass index between 18.0 and 30.0 kg/m² inclusive.
  • Serum LDL-C levels >100 mg/dL

Exclusion Criteria:

  • Subject indicated for the use of statins according to criteria in Adult Treatment Panel (ATP) III Guidelines as updated in 2004
  • Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, dermatological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the subject's participation in this study.
  • History or presence of drug or alcohol abuse
  • Smoking more than 5 cigarettes or equivalent in any 24 hour period.
  • Any medication (including St John's Wort) within 14 days before the inclusion or within 5 times the elimination half-life or pharmacodynamic (PD) half-life of that drug, whichever the longest; any vaccination within the last 28 days.
  • Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies, syphilis.
  • Elevated cholesterol due to a secondary cause such as hypothyroidism or alcohol.
  • Presence or history of drug hypersensitivity
  • Initiation of a new exercise routine or major change to a previous exercise routine within 4 weeks prior to Screening.
  • Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448317

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01448317     History of Changes
Other Study ID Numbers: TDU12190  U1111-1118-1213 
Study First Received: September 21, 2011
Last Updated: September 27, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016