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AZD2820

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 21, 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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01332214To Assess the Safety, Tolerability and Pharmacokinetics of AZD2820 After Single Ascending DosesPHASE1 COMPLETED 90May 1, 2011Nov 1, 2011Nov 21, 20111 United Kingdom
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Study Endpoints
Primary Endpoints
Safety variables ( Adverse events, Vital signs, ECG, EEG, Regiscan, Safety labs.)
Assessments performed multilpe times from the morning day 1 before dose until day 3. And then once at the follow up after 14-18 days
Secondary Endpoints
To evaluate the pharmacokinetics of AZD2820 and assess the dose proportionality of the pharmacokinetics following single ascending doses of AZD2820 by assessment Cmax, tmax, t1/2 , AUC, CL/F, Ae and CLR.
Blood samples will be taken multiple times from the morning day 1 before dose until day 2
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD2820EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AZD2820DRUGSubcutaneous Injection in abdomen or Thigh
PlaceboDRUGSubcutaneous Injection in abdomen or Thigh
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Eligibility Criteria
Age Range20 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 ≥20 - ≤45 years with suitable veins for cannulation or repeated venepuncture. * Male subjects should be willing to use barrier contraception ie, condoms...

Countries:United Kingdom
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