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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01537653
Collaborator
Regeneron Pharmaceuticals (Industry)
32
Enrollment
1
Location
5
Arms
7
Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Mar 1, 2012
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Oct 1, 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) [Up to 57 days]

Secondary Outcome Measures

  1. Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time [Up to 57 days]

  2. Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time [Up to 57 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Investigational Site Number 392001 Toshima-Ku Japan 171-0014

Sponsors and Collaborators

  • Sanofi
  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT01537653
Other Study ID Numbers:
  • TDU12265
  • U1111-1127-2719
First Posted:
Feb 23, 2012
Last Update Posted:
Dec 6, 2013
Last Verified:
Nov 1, 2012

Study Results

No Results Posted as of Dec 6, 2013