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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: SAR231893 (REGN668)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01537653

TDU12265

U1111-1127-2719 (Other Identifier)

Details and patient eligibility

About

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)

Full 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

Enrollment: 32 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 5 patient groups, including a placebo group

SAR231893 (REGN668), Dose Level 4

Experimental group

Description:

Dose Level 4

Treatment:

Drug: SAR231893 (REGN668)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

SAR231893 (REGN668), Dose Level 1

Experimental group

Description:

Dose Level 1

Treatment:

Drug: SAR231893 (REGN668)

SAR231893 (REGN668), Dose Level 2

Experimental group

Description:

Dose Level 2

Treatment:

Drug: SAR231893 (REGN668)

SAR231893 (REGN668), Dose Level 3

Experimental group

Description:

Dose Level 3

Treatment:

Drug: SAR231893 (REGN668)