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AZD2115

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 30, 2021

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
ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03097380PET Study to Determine Muscarinic Receptor Occupancy in Lungs After Inhalation of AZD2115 and TiotropiumPHASE1 COMPLETED 19Apr 26, 2017Dec 30, 2017Aug 30, 20211 Sweden
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Study Endpoints
Primary Endpoints
Reduction in distribution volume (VT)%
up to 9 h post dose

To describe the AZD2115 dose-muscarinic receptor occupancy relationship in the lungs in healthy volunteers

Secondary Endpoints
Receptor occupancy (RO) %
up to 9 h post dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
AZD2115EXPERIMENTAL -
Spiriva (Tiotropium)ACTIVE_COMPARATOR -
[11C]AZ13754366EXPERIMENTAL -
Interventions
NameTypeDescription
AZD2115DRUGAZD2115
SPIRIVADRUGTiotropium
[11C]AZ13754366RADIATIONRadioligand
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Eligibility Criteria
Age Range20 Years — 50 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 50 years (inclusive) * Male subjects must be surgically sterile or use an acceptable method of contraception (defined as barrier methods in conjunc...

Countries:Sweden
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