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AMG 282

Phase 1

Asthma | Small molecule | Respiratory |Amgen Inc.|Last Updated: Dec 14, 2016

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01928368A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.PHASE1 COMPLETED 70Aug 1, 2013Mar 1, 2016Dec 14, 20165 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment emergent adverse events
Up to day 141
Incidence of abnormal clinically significant vital signs
Up to day 141
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
Up to day 141
Incidence of abnormal clinically significant ECG results
Up to day 141
Incidence of anti-AMG 282 antibodies
Up to 1 year
Secondary Endpoints
Determination of various PK parameters including tmax, AUClast and Cmax
Up to day 141
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental ArmACTIVE_COMPARATOR -
Placebo ArmPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AMG 282DRUGSingle dose either subcutaneously or intravenously on day 1.
AMG 282 Matching PlaceboDRUGSingle dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria (All subjects) * Is a current non-smoker, has not used any nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) within the last 6 months, and cumulative smoking history is ≤10 pack years. * ...

Countries:United States
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