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AZD2423

Phase 1

Healthy Volunteer | Small molecule | Other |AstraZeneca PLC|Last Updated: Mar 18, 2010

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 Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00970775AZD2423 Single Ascending Dose Study in Healthy Japanese SubjectsPHASE1 COMPLETED 32 — — Aug 1, 2009Dec 1, 2009Mar 18, 20102 United Kingdom
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Study Endpoints
Primary Endpoints
To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.
From screening period to follow-up visit, 40 days (Maximum).
Secondary Endpoints
To characterize the pharmacokinetics of AZD2423 in plasma and urine.
Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)
Exploratory endpoints;Levels of CCL2 pre-and post dose
Blood sampling after dosing, 3 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1. AZD2423EXPERIMENTAL -
2. PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD2423DRUGoral solution, single dose
PlaceboDRUGoral solution,single dose
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Eligibility Criteria
Age Range20 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture. * Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2 * Clinically normal physical findings including supine blood pressur...

Countries:United Kingdom
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