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NCT01537653

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

NCT ID: NCT01537653

Last Updated: 2013-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SAR231893 (REGN668), Dose Level 4

Dose Level 4

Group Type EXPERIMENTAL

SAR231893 (REGN668)

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

SAR231893 (REGN668), Dose Level 1

Dose Level 1

Group Type EXPERIMENTAL

SAR231893 (REGN668)

Intervention Type DRUG

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

SAR231893 (REGN668), Dose Level 2

Dose Level 2

Group Type EXPERIMENTAL

SAR231893 (REGN668)

Intervention Type DRUG

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

SAR231893 (REGN668), Dose Level 3

Dose Level 3

Group Type EXPERIMENTAL

SAR231893 (REGN668)

Intervention Type DRUG

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

Interventions

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SAR231893 (REGN668)

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 392001

Toshima-Ku, , Japan

Site Status

Countries

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Japan

References

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Li Z, Radin A, Li M, Hamilton JD, Kajiwara M, Davis JD, Takahashi Y, Hasegawa S, Ming JE, DiCioccio AT, Li Y, Kovalenko P, Lu Q, Ortemann-Renon C, Ardeleanu M, Swanson BN. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. Clin Pharmacol Drug Dev. 2020 Aug;9(6):742-755. doi: 10.1002/cpdd.798. Epub 2020 Apr 29.

Reference Type DERIVED

PMID: 32348036 (View on PubMed)

Other Identifiers

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U1111-1127-2719

Identifier Type: OTHER

Identifier Source: secondary_id

TDU12265

Identifier Type: -

Identifier Source: org_study_id