Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
December 5, 2013 updated by: Sanofi
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
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Toshima-Ku, Japan, 171-0014
- Investigational Site Number 392001
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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PLACEBO_COMPARATOR: Placebo
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Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
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EXPERIMENTAL: SAR231893 (REGN668), Dose Level 4
Dose Level 4
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Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
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EXPERIMENTAL: SAR231893 (REGN668), Dose Level 1
Dose Level 1
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Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
|
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EXPERIMENTAL: SAR231893 (REGN668), Dose Level 2
Dose Level 2
|
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
|
|
EXPERIMENTAL: SAR231893 (REGN668), Dose Level 3
Dose Level 3
|
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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Up to 57 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time
Time Frame: Up to 57 days
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Up to 57 days
|
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Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time
Time Frame: Up to 57 days
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Up to 57 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
October 1, 2012
Study Completion (ACTUAL)
October 1, 2012
Study Registration Dates
First Submitted
February 17, 2012
First Submitted That Met QC Criteria
February 17, 2012
First Posted (ESTIMATE)
February 23, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
December 6, 2013
Last Update Submitted That Met QC Criteria
December 5, 2013
Last Verified
November 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- TDU12265
- U1111-1127-2719 (OTHER: UTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.