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REGN2222

Phase 1

Healthy Volunteers | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Nov 4, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02828397Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy SubjectsPHASE1 COMPLETED 28 — — Apr 1, 2016Sep 1, 2016Nov 4, 20162 United States
NCT02121080Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult VolunteersPHASE1 COMPLETED 132 — — May 1, 2014Feb 1, 2015Mar 11, 20153 United States
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Study Endpoints
Primary Endpoints
Serum REGN2222 concentration-time curve (AUC)
Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)
Day 1 to Day 148 (end of study)
The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.
from day 1 up to week 20 (EOS)
Secondary Endpoints
Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)
Day 1 to Day 148 (end of study)
Serum concentration
from day 1 over time up to week 20
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Reference DrugEXPERIMENTALREGN2222 Reference Formulation
Test DrugEXPERIMENTALREGN2222 Test Formulation
Cohort 1EXPERIMENTALDosing regimen 1
Cohort 2EXPERIMENTALDosing regimen 2
Cohort 3EXPERIMENTALDosing regimen 3
Cohort 4EXPERIMENTALDosing regimen 4
Cohort 5EXPERIMENTALDosing regimen 5
Interventions
NameTypeDescription
REGN2222DRUG -
REGN2222(SAR438584)DRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion Criteria: 1. Healthy man or woman aged 18 to 60 years 2. Body weight between 50.0 kg and 95.0 kg, inclusive 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent Key Exclusion Criteria: 1. Hemoglobin not within normal limits...

Countries:United States
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