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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01448239
First received: October 5, 2011
Last updated: June 27, 2013
Last verified: February 2012
  Purpose

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)

Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pain using present pain intensity (PPI) verbal questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Erythema at injection site by measuring diameter and qualitative assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Edema at injection site by measuring diameter and qualitative assessment [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of PK parameter - time to maximum concentration (tmax) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - maximum concentration (Cmax) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - area under curve (AUC) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of PK parameter - terminal elimination half-life (t1/2z) [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Change in LDL-C from baseline [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with Adverse Events [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: February 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727) - Dose A
A single subcutaneous injection of Dose A
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution Route of administration: Subcutaneous
Experimental: alirocumab SAR236553 (REGN727) - Dose B
A single subcutaneous injection of Dose B
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution Route of administration: Subcutaneous

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  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: NCT01448239

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01448239     History of Changes
Other Study ID Numbers: PKD12010, U1111-1118-2935
Study First Received: October 5, 2011
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 14, 2014