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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01537653

Enrollment

Registered

2012-02-23

Start date

2012-03-31

Completion date

2012-10-31

Last updated

2013-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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)

Detailed 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

Interventions

DRUGSAR231893 (REGN668)

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026