Safety, Tolerability and Pharmacokinetics of SAR231893 (REGN668) in Healthy Japanese Adult Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: SAR231893 (REGN668)Drug: placebo
- Registration Number
- NCT01537653
- Lead Sponsor
- Sanofi
- 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)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR231893 (REGN668), Dose Level 4 SAR231893 (REGN668) Dose Level 4 Placebo placebo Placebo SAR231893 (REGN668), Dose Level 1 SAR231893 (REGN668) Dose Level 1 SAR231893 (REGN668), Dose Level 2 SAR231893 (REGN668) Dose Level 2 SAR231893 (REGN668), Dose Level 3 SAR231893 (REGN668) Dose Level 3
- Primary Outcome Measures
Name Time Method 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
Name Time Method Pharmacokinetics: Serum concentrations of SAR231893 (REGN668) over time Up to 57 days Pharmacodynamics: Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time Up to 57 days
Trial Locations
- Locations (1)
Investigational Site Number 392001
🇯🇵Toshima-Ku, Japan