Comparison of the Pharmacokinetics and Safety of Two SAR231893 (REGN668) Drug Products in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: SAR231893 (REGN668) DP1Biological: SAR231893 (REGN668) DP2
- Registration Number
- NCT01537640
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose
Secondary Objective:
To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose
- Detailed Description
The duration of the study for each subject is 8-11 weeks broken down as follows:
* Screening: 2 to 21 days,
* Treatment: 1 day (2 overnight stays at the study site),
* Follow-up: up to 2 months after dosing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR231893 (REGN668) Drug Product (DP) 1 SAR231893 (REGN668) DP1 SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection SAR231893 (REGN668) Drug Product (DP) 2 SAR231893 (REGN668) DP2 SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection
- Primary Outcome Measures
Name Time Method Assessment of serum concentrations of SAR231893 (REGN668) Up to 57 Days
- Secondary Outcome Measures
Name Time Method Erythema at injection site by measuring diameter Up to 8 Days Number of participants experiencing adverse events Up to 57 Days Pain evaluation at injection site using Visual Analog Scale (VAS) Up to 8 Days Edema at injection site by measuring diameter Up to 8 Days
Trial Locations
- Locations (1)
Investigational Site Number 840001
🇺🇸Daytona Beach, Florida, United States