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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01537653
First received: February 17, 2012
Last updated: December 5, 2013
Last verified: November 2012
  Purpose

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 Intervention Phase
Healthy
Drug: SAR231893 (REGN668)
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time [ Time Frame: Up to 57 days ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time [ Time Frame: Up to 57 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01537653     History of Changes
Other Study ID Numbers: TDU12265, U1111-1127-2719
Study First Received: February 17, 2012
Last Updated: December 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on April 15, 2014