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AZD1390

Phase 1

Healthy Volunteer Male Subjects | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 26, 2018

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03215381AZD1390 Administration of a Microdose [11C]AZD1390 to Healthy VolunteersPHASE1 COMPLETED 8Oct 10, 2017Feb 19, 2018Feb 26, 20181 Sweden
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Study Endpoints
Primary Endpoints
Brain distribution of AZD1390
up to 2 hours post dose

To assess if 11C AZD1390 crosses the blood brain barrier in healthy volunteers

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
[11C]AZD1390 MicrodoseOTHER\[11C\]AZD1390 single dose not exceeding 10 ug by IV bolus
Interventions
NameTypeDescription
[11C]AZD1390DRUG\[11C\]AZD1390
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Eligibility Criteria
Age Range20 Years — 65 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 to 65 years (inclusive). * Subject should be healthy as determined by medical history, physical examination, laboratory parameters, ECG and brain MR...

Countries:Sweden
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