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AZD2927

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: May 24, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01264250A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male VolunteersPHASE1 COMPLETED 48 — — Jan 1, 2011May 1, 2011May 24, 20111 Sweden
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Study Endpoints
Primary Endpoints
Safety and tolerability of AZD2927, at screening
Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening
Safety and tolerability of AZD2927, day 1
Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.
Safety and tolerability of AZD2927, day 2
Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.
Safety and tolerability of AZD2927, day 3
Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.
Safety and tolerability of AZD2927, at follow up
Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.
Secondary Endpoints
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1
Pharmacokinetic sampling will be performed day 1
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2
Pharmacokinetic sampling will be performed day 2
Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3
Pharmacokinetic sampling will be performed day 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD2927DRUGSingle dose of AZD2927
PlaceboDRUGSingle dose of placebo
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male subjects aged 18 to 45 years inclusive with suitable veins for cannulation or repeated venepuncture * Male subjects should be willing to use barrier contraception ie, ...

Countries:Sweden
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