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

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Ascending Single Subcutaneous Doses of SAR231893/REGN668 in Healthy Japanese Adult Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537653
• Other study ID #: TDU12265
• Secondary ID: U1111-1127-2719
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2012
• Last updated: December 5, 2013
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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)

Description:

Total duration of the study period per subject is 11 weeks broken down as follows:

Screening period = 2 to 21 days Treatment period = 57 days, including 1 treatment day

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion criteria:

• Japanese adult male subjects, between 20 and 45 years of age, inclusive.

• Body weight between 50.0 and 95.0 kg, inclusive, body mass index between 18.0 and 28.0 kg/m2, inclusive.

• Certified as healthy by a comprehensive clinical assessment.

• Having given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria:

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.

• Any subject who cannot prohibit intensive physical activity throughout the study duration.

• Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti-hepatitis B core antibodies (anti-HBc Ab), anti-hepatitis C virus (anti-HCV) antibodies, human immunodeficiency virus (HIV) antigen and antibodies.

• Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).

• Serum alcohol level over the upper limit of normal range (ULN).

• Previous exposure to any therapeutic or investigational biological agent.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
• placebo
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Toshima-Ku

Sponsors (2)

Lead Sponsor	Collaborator
Sanofi	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)		Up to 57 days	Yes
Secondary	Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time		Up to 57 days	No
Secondary	Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time		Up to 57 days	No