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REGN3500

Phase 1

Healthy Volunteers | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Nov 8, 2017

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02958436A Study of Intravenously or Subcutaneously Administered REGN3500 in Healthy Adult SubjectsPHASE1 COMPLETED 40 — — Aug 1, 2016Oct 3, 2017Nov 8, 20171 Belgium
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Study Endpoints
Primary Endpoints
The incidence and severity of treatment-emergent adverse events in subjects treated with REGN3500
Up to 293 days after dosing
Secondary Endpoints
Obtain the pharmacokinetic parameters (Cmax) that describe the serum concentration time profile of REGN3500
Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Obtain the pharmacokinetic parameters (Tmax) that describe the serum concentration time profile of REGN3500
Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
Obtain the pharmacokinetic parameters (AUClast) that describe the serum concentration time profile of REGN3500
Obtain serum samples pre-dose, immediately post-dose (infusion or injection end), 1, 2, 4, 8 (for subcutaneous) and 12 (for intravenous) hours after dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALDose regimen 1 of REGN3500 (IV) versus placebo
Cohort 2EXPERIMENTALDose regimen 2 of REGN3500 (IV) versus placebo
Cohort 3EXPERIMENTALDose regimen 3 of REGN3500 (IV) versus placebo
Cohort 4EXPERIMENTALDose regimen 4 of REGN3500 (SC) versus placebo
Cohort 5EXPERIMENTALDose regimen 5 of REGN3500 (IV) versus placebo
Interventions
NameTypeDescription
REGN3500DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index\</= 33 kg/m2 * In good health based on medical history, physical examination, vital signs, and laboratory testing * Normal electrocardiogram (ECG) and blood pressure * Able to comply with clinic visits and study-related procedures * Able to sign an informed con...

Countries:Belgium
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