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Biological: AZD3152

Phase 2

COVID-19, SARS-CoV-2 | Monoclonal antibody | Infectious Disease |AstraZeneca PLC|Last Updated: Aug 15, 2025

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment116
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06057064Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19PHASE2 COMPLETED 116Sep 29, 2023May 17, 2024Aug 15, 20256 Russia
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Study Endpoints
Primary Endpoints
The Number and Proportion of Subjects With AEs, SAEs, MAAEs, AESIs.
up to Day 181

The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data

Secondary Endpoints
Geometric Mean Titer (GMT) of nAbs Against SARS-CoV-2 Emerging Dominant Variant(s)
up to Day 181
Geometric Mean Fold Rise (GMFRs) of nAb Titers Against SARS-CoV-2 Emerging Dominant Variant(s)
up to Day 181
Incidence of a Post-treatment Symptomatic COVID-19 Case
up to Day 181
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATORSingle dose of Placebo IM (0.9% sodium chloride)
AZD3152EXPERIMENTALSingle dose of 300 mg IM
Interventions
NameTypeDescription
Biological: AZD3152BIOLOGICAL300 mg single dose of AZD3152 IM
Biological: PlaceboBIOLOGICALSingle dose of Placebo IM (0.9% sodium chloride)
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Participant must be 18 years of age or older at the time of signing the informed consent. * Weight ≥ 45 kg at Visit 1. * Participants must satisfy at least 1 of the following risk factors at enrollment: 1. Obese, ie, BMI ≥ 30 2. Congestive heart failure 3. Chronic obstr...

Countries:Russia
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