Injection Site Tolerability, Safety, Pharmacokinetics, Pharmacodynamics in Different Single-Dose Treatments of Alirocumab SAR236553 (REGN727) in Healthy Subjects

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT01443650
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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)

Key Dates

Start date
Jul 31, 2011
Status verified
Feb 2012
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: alirocumab SAR236553 (REGN727) (Formulation A x 1)
    A single subcutaneous injection of Formulation A
  • Experimental: alirocumab SAR236553 (REGN727) (Formulation B x 1)
    A single subcutaneous injection of Formulation B
  • Experimental: alirocumab SAR236553 (REGN727) (Formulation A x 2)
    2 single subcutaneous injections of Formulation A

Primary Outcome Measure

Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS) [ Time Frame: 15 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey--

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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