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

Sanofi32 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

SAR231893 (REGN668)DRUG

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

placeboDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Investigational Site Number 392001

Toshima-Ku, Japan

Outcomes

Primary Outcomes

Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests)

Time frame: Up to 57 days

Secondary Outcomes

Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time

Time frame: Up to 57 days

Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time

Time frame: Up to 57 days

Data from ClinicalTrials.gov

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