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AMG 853

Phase 1

Healthy Volunteers | Small molecule | Other |Amgen Inc.|Last Updated: Jan 7, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01124279Single-dose, Pharmacokinetics of AMG 853 in Healthy Adult SubjectsPHASE1 COMPLETED 43May 1, 2010Oct 1, 2010Jan 7, 2011 -
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Study Endpoints
Primary Endpoints
Pharmacokinetic parameters
throughout study duration
Secondary Endpoints
Treatment-emergent adverse events, safety and laboratory assessments
throughout study duration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AMG 853EXPERIMENTAL -
Interventions
NameTypeDescription
AMG 853DRUGSingle dose administration of AMG 853 in tablet form to healthy adult subjects
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Non-nicotine or tobacco using, healthy male and/or female subjects between 18 and 55 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician * Females must be of no...

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