Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
This study has been completed.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01537653
First received: February 17, 2012
Last updated: November 8, 2012
Last verified: November 2012
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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 |
Biological: 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
|
Biological: 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
|
Biological: SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
|
|
Experimental: SAR231893 (REGN668), Dose Level 2
Dose Level 2
|
Biological: SAR231893 (REGN668)
Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
|
|
Experimental: SAR231893 (REGN668), Dose Level 3
Dose Level 3
|
Biological: 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 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: | November 8, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ClinicalTrials.gov processed this record on May 19, 2013