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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014