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REGN3470-3471-3479

Phase 1

Healthy Volunteers | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 5, 2018

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-BlindCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02777151Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult VolunteersPHASE1 COMPLETED 24 — — May 27, 2016Apr 26, 2017Feb 5, 20181 United States
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Study Endpoints
Primary Endpoints
Incidence and severity of TEAEs through the end of the study visit in subjects treated with REGN3470-3471-3479 in a fixed dose combination
From baseline up to day 169
Secondary Endpoints
Concentration of REGN3479 in serum over time
From baseline up to day 169
Concentration of REGN3471 in serum over time
From baseline up to day 169
Concentration of REGN3470 in serum over time
From baseline up to day 169
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALREGN3470-3471-3479 dosing level 1 or placebo
Cohort 2EXPERIMENTALREGN3470-3471-3479 dosing level 2 or placebo
Cohort 3EXPERIMENTALREGN3470-3471-3479 dosing level 3 or placebo
Cohort 4EXPERIMENTALREGN3470-3471-3479 dosing level 4 or placebo
Interventions
NameTypeDescription
REGN3470-3471-3479DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy man or woman between the ages of 18 and 60 2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent 5. Able to understand and complete study-related que...

Countries:United States
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