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REGN728

Phase 1

Healthy | Monoclonal antibody | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Nov 12, 2012

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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01197391Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy VolunteersPHASE1 COMPLETED 48 — — Aug 1, 2010Mar 1, 2012Nov 12, 20122 United States
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Study Endpoints
Primary Endpoints
The primary endpoint in the study is the percentage of subjects with treatment emergent adverse events, reported from the administration of study drug on day 1 to the completion of the study on day 106.
106 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALDose 1 versus placebo
Cohort 2EXPERIMENTALDose 2 versus placebo
Interventions
NameTypeDescription
REGN728BIOLOGICAL2 Subcutaneous Cohorts (dose 1, 2)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male or female 18 to 65 years of age. * Weight\> 50 kg and \<95 kg inclusive * For men of childbearing potential, willingness to utilize adequate contraception and not have their partner\[s\] become pregnant during the full duration of the study. * Willing, committed, and able...

Countries:United States
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