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AZD8848

Phase 1

Butyrylcholinesterase Deficiency | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 14, 2015

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 Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01205867Study to Investigate the Safety and Tolerability of AZD8848 in Butyrylcholinesterase Deficient SubjectsPHASE1 COMPLETED 22 — — Sep 1, 2010Jan 1, 2012Aug 14, 20151 Denmark
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Study Endpoints
Primary Endpoints
Safety and tolerability will be assessed by a panel of measurements including adverse events (AEs), vital signs, ECG, laboratory variables, physical examination, and clinical inspection of the nose
Immediately prior to administration of the IP (Day 0)
Secondary Endpoints
Pharmacokinetics (concentration of AZD8848 and metabolite in plasma and urine)
Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.
Pharmacodynamics (IL-1Ra in plasma)
Prior to administration of the IP (Day 0) and repeated assessments during the first 48h.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD8848 given to BChE deficient subjects and age \& gender matched control subjects
Interventions
NameTypeDescription
AZD8848DRUGNasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BChE deficient subjects: The half-live of AZD8848 in plasma should be more than 20 minutes in an in vitro screening test * Matched control subject: The half-live of AZD8848 in plasma should be less than 2 minutes in an in vitro screening test Exclusion Criteria: * Any clinic...

Countries:Denmark
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