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AZD5122

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 4, 2009

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
NCT00984477Study to Investigate the Activity of AZD5122 When Given as a Single Dose to Healthy Male SubjectsPHASE1 COMPLETED 100Sep 1, 2009Nov 1, 2009Dec 4, 20091 United Kingdom
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Study Endpoints
Primary Endpoints
Pharmacokinetic profile: concentration of AZD5122 in blood
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Secondary Endpoints
Pharmacokinetic profile: concentration of AZD5122 in urine
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Measurement of the effect of AZD5122 on circulating neutrophils
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.
Pharmacodynamic profile: assessment of various pharmacodynamic measures
Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 48 hours post-dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD5122 oral suspension (part A and B)
2PLACEBO_COMPARATORPlacebo oral suspension (part A)
3EXPERIMENTALAZD5122 oral and IV infusion (part B)
Interventions
NameTypeDescription
AZD5122DRUGA single dose of oral suspension
PlaceboDRUGA single dose of oral suspension
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Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent. * Normal physical examination, laboratory values, blood pressure and pulse * Healthy male caucasian subjects Exclusion Criteria: * Subjects must not have any history of gastrointestinal, hepatic or renal disease, or an...

Countries:United Kingdom
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