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AZD9819

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 9, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01166698Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy SubjectsPHASE1 COMPLETED 100Aug 1, 2010Jan 1, 2011Nov 9, 20111 United Kingdom
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Study Endpoints
Primary Endpoints
Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)
Frequent safety measurements during the study from screening period to follow-up
Secondary Endpoints
Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma
Multiple PK blood samples from pre-dose until 96 hours post last dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD9819EXPERIMENTALInhaled suspension
PlaceboPLACEBO_COMPARATORInhaled suspension
Interventions
NameTypeDescription
AZD9819DRUGInhaled single doses of suspension via SPIRA nebuliser
PlaceboDRUGInhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. * Have a body mass index (BMI) betw...

Countries:United Kingdom
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