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MEDI7352 for infusion

Phase 1

Chronic Pain | Monoclonal antibody | Pain |AstraZeneca PLC|Last Updated: Apr 15, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment132
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02508155A Study of MEDI7352 in Painful Osteoarthritis of the KneePHASE1 COMPLETED 132Nov 17, 2015Dec 23, 2020Apr 15, 20216 Germany, Sweden +1
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Study Endpoints
Primary Endpoints
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of MEDI7352
All visits from screening up to 56 days post single dose/84 days post multiple dose

Adverse events, serious adverse events,

Secondary Endpoints
Area under the plasma drug concentration versus time curves for MEDI7352
All visits from screening up to 56 days post single dose/84 days post multiple dose
Maximum observed plasma drug concentration (Cmax) of MEDI7352
All visits from screening up to 56 days post single dose/84 days post multiple dose
Time to maximum observed plasma drug concentration (Tmax) of MEDI7352
All visits from screening up to 56 days post single dose/84 days post multiple dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
MEDI7352 IVEXPERIMENTALUp to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
IV PlaceboPLACEBO_COMPARATORUp to 11 cohorts of subjects are planned to be dosed by IV infusion, with single and multiple ascending doses.
MEDI7352 Subcutaneous InjectionEXPERIMENTAL1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
Subcutaneous PlaceboPLACEBO_COMPARATOR1 cohort of subjects is planned to be dosed by subcutaneous injection, one single ascending dose cohort.
Interventions
NameTypeDescription
MEDI7352 for IV infusionBIOLOGICALMEDI7352 for IV infusion
Placebo for IV infusionBIOLOGICALIV Placebo infusion
MEDI7352 for Subcutaneous InjectionBIOLOGICALMEDI7352 for subcutaneous injection
Placebo for Subcutaneous InjectionBIOLOGICALSubcutaneous Placebo Injection
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Male and female subjects with painful osteoarthritis (OA) of the knee. Female subjects must be postmenopausal or surgically sterile. * Body weight between 50kg and 145kg * Willing and able to comply with the requirements of the protocol Exclusion Criteria: * Current treatmen...

Countries:GermanySwedenUnited Kingdom
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