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

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT01448239
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
Feb 28, 2011
Status verified
Feb 2012
Primary completion
May 31, 2011
Completion
May 31, 2011

Study Design

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

Arms

  • Experimental: alirocumab SAR236553 (REGN727) - Dose A
    A single subcutaneous injection of Dose A
  • Experimental: alirocumab SAR236553 (REGN727) - Dose B
    A single subcutaneous injection of Dose B

Primary Outcome Measure

Pain using present pain intensity (PPI) verbal questionnaire [ Time Frame: 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey--

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Sanofi-Aventis Administrative Office· Bridgewater, NJ

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