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

NCT01448317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-09-28

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Alirocumab (Solution)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Alirocumab (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation Route of administration: subcutaneous

DRUG

Placebo (Solution)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Placebo (Lyophilized formulation)

Pharmaceutical form: lyophilized formulation Route of administration: Subcutaneous

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01448317 on ClinicalTrials.gov