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

Study Overview
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Brief Summary
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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)

Detailed Description
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: SAR231893 (REGN668)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR231893 (REGN668), Dose Level 4<br>Dose Level 4 | Drug: SAR231893 (REGN668)<br>* Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection<br>|
| Experimental: SAR231893 (REGN668), Dose Level 1<br>Dose Level 1 | Drug: SAR231893 (REGN668)<br>* Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection<br>|
| Experimental: SAR231893 (REGN668), Dose Level 2<br>Dose Level 2 | Drug: SAR231893 (REGN668)<br>* Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection<br>|
| Experimental: SAR231893 (REGN668), Dose Level 3<br>Dose Level 3 | Drug: SAR231893 (REGN668)<br>* Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with standard safety assessments (adverse events, physical examinations, 12 lead ECGs, vital signs and laboratory tests) |  | Up to 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time |  | Up to 57 days | 
| Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time |  | Up to 57 days |