MedTrace Logo

Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects

NCT01537653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-12-06

No results posted yet for this study

Summary

Primary Objective:

Assess the safety and tolerability of SAR231893 (REGN668) after ascending single subcutaneous (SC) doses in healthy Japanese adult male subjects

Secondary Objectives:

Assess the following parameters after ascending single SC doses in healthy Japanese adult male subjects

* The pharmacokinetics of SAR231893 (REGN668)
* The immunogenicity of SAR231893 (REGN668)
* Exploratory analyses of the pharmacodynamics of SAR231893 (REGN668)

Conditions

  • Healthy

Interventions

DRUG

SAR231893 (REGN668)

Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection

DRUG

placebo

Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection

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
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Japan

More Related Trials

Entities

Drugs
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 NCT01537653 on ClinicalTrials.gov