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REGN1500

Phase 1

Metabolic Disorders | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Sep 30, 2015

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 Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02107872Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500PHASE1 COMPLETED 55Apr 1, 2014Sep 1, 2015Sep 30, 20154 United States
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Study Endpoints
Primary Endpoints
Safety
visit 1 to day 183 (EOS)

Safety of REGN1500 will be assessed by physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations from visit 1 to day 183 \[EOS (end of study)\]

Secondary Endpoints
Serum concentration
visit 1 to day 183
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
dosing cohort 1EXPERIMENTALPatients will receive REGN1500 or placebo in dosing cohort 1
dosing cohort 2EXPERIMENTALPatients will receive REGN1500 or placebo in dosing cohort 2
dosing cohort 3EXPERIMENTALPatients will receive REGN1500 or placebo in dosing cohort 3
dosing cohort 4EXPERIMENTALPatients will receive REGN1500 or placebo in dosing cohort 4
dosing cohort 5EXPERIMENTALPatients will receive REGN1500 or placebo in dosing cohort 5
Interventions
NameTypeDescription
REGN1500DRUG -
placeboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Provide signed informed consent * Otherwise healthy men and women ages 18 to 65 years, inclusive * Body mass index of 18.0 kg/m2to 38.0 kg/m2, inclusive * Normal standard 12-lead ECG * Willing to refrain from the consumption of alcohol for 24 hours prior to each study visit * ...

Countries:United States
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Competitive Landscape -Metabolic Disorders 7 trials
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