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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: alirocumab SAR236553 (REGN727)

• Registration Number: NCT01443650
• Lead Sponsor: Sanofi

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

Total duration for each subject (not including screening) will be approximately 85 days.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-30
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alirocumab SAR236553 (REGN727) (Formulation A x 2)	alirocumab SAR236553 (REGN727)	2 single subcutaneous injections of Formulation A
alirocumab SAR236553 (REGN727) (Formulation A x 1)	alirocumab SAR236553 (REGN727)	A single subcutaneous injection of Formulation A
alirocumab SAR236553 (REGN727) (Formulation B x 1)	alirocumab SAR236553 (REGN727)	A single subcutaneous injection of Formulation B

Primary Outcome Measures

Name	Time	Method
Pain using Present Pain Intensity (PPI) verbal questionnaire and Visual Analog Scale (VAS)	15 days
Erythema at injection site by measuring diameter and qualitative assessment	15 days
Edema at injection site by measuring diameter and qualitative assessment	15 days

Secondary Outcome Measures

Name	Time	Method
Assessment of PK parameter - time to maximum concentration (tmax)	Up to 85 days
Pharmacodynamics: Change in LDL-C from baseline	Up to 85 days
Number of participants with Adverse Events	Up to 85 days
Assessment of PK parameter - maximum concentration (Cmax)	Up to 85 days
Assessment of PK parameter - area under curve (AUC)	Up to 85 days
Assessment of PK parameter - area under curve versus time curve (AUC0-D29)	Zero to Day 29
Assessment of PK parameter - plasma concentration on Day 29 (C D29)	Day 29
Assessment of PK parameter - terminal elimination half-life (t1/2z)	Up to 85 days

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States