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

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ClinicalTrials.gov Identifier: NCT01537653
Recruitment Status : Completed
First Posted : February 23, 2012
Last Update Posted : December 6, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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)

Condition or disease Intervention/treatment Phase
Healthy Drug: SAR231893 (REGN668) Drug: placebo Phase 1

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Primary Completion Date : October 2012
Study Completion Date : October 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: SAR231893 (REGN668), Dose Level 4
Dose Level 4
Drug: SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
Placebo Comparator: Placebo
Placebo
Drug: placebo
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
Experimental: SAR231893 (REGN668), Dose Level 1
Dose Level 1
Drug: SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
Experimental: SAR231893 (REGN668), Dose Level 2
Dose Level 2
Drug: SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
Experimental: SAR231893 (REGN668), Dose Level 3
Dose Level 3
Drug: SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time [ Time Frame: Up to 57 days ]
  2. Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time [ Time Frame: Up to 57 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537653


Locations
Japan
Investigational Site Number 392001
Toshima-Ku, Japan, 171-0014
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01537653     History of Changes
Other Study ID Numbers: TDU12265
U1111-1127-2719 ( Other Identifier: UTN )
First Posted: February 23, 2012    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: November 2012