Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects
- Registration Number
- NCT02828397
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Primary Objective: Determine blood concentrations of two formulations of REGN2222
Secondary Objective: Assess safety and tolerability of REGN2222
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
- Healthy man or woman aged 18 to 60 years
- Body weight between 50.0 kg and 95.0 kg, inclusive
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Key
Exclusion Criteria
- Hemoglobin not within normal limits
- Positive drug and alcohol screen test results at screening visits 1 and 2
- Participation in any clinical research study that evaluated another investigational drug or therapy within 30 days or at least 5 half-lives, whichever is longer, of the investigational drug, prior to the screening visit
- Pregnant or breastfeeding women, and women of childbearing potential
- Sexually active men who are unwilling to practice adequate contraception during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference Drug REGN2222 REGN2222 Reference Formulation Test Drug REGN2222 REGN2222 Test Formulation
- Primary Outcome Measures
Name Time Method Peak REGN2222 concentration (Cmax) Day 1 to Day 148 (end of study) Serum REGN2222 concentration-time curve (AUC) Day 1 to Day 148 (end of study)
- Secondary Outcome Measures
Name Time Method Presence or absence of anti-drug antibody (ADA) Day 1 to Day 148 (end of study) Treatment-emergent adverse events (TEAEs) from baseline to the end of the study Day 1 to Day 148 (end of study)