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AZ14132516

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 14, 2023

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
NCT05818514A PET Study to Determine Biodistribution and Binding Characteristics of [11C]AZ14132516 in Healthy ParticipantsEARLY_PHASE1 COMPLETED 8Apr 27, 2023Jul 11, 2023Jul 14, 20231 Sweden
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Study Endpoints
Primary Endpoints
SUV and SUVR in abdominal regions of interest
Immediately following administration of radioligand

Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight. Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake

Secondary Endpoints
Absolute percentage differences of SUV and SUVR, and intraclass correlation coefficients, in regions of interest between two test-retest PET examinations
10-14 days following initial administration of radioligand
Number of participants with safety findings, AEs
Through study completion, up to 49 days (including screening period)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
[11C]AZ14132516EXPERIMENTALPilot panel: up to 3 participants to complete 1 PET examination each during the course of the study Main panel: up to 6 participants to complete 2 PET examinations each during the course of the study
Interventions
NameTypeDescription
[11C]AZ14132516DRUGInjection of radioligand for PET examinations
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Eligibility Criteria
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Informed Consent 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. 2. Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete a...

Countries:Sweden
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