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AZD7053

Phase 1

Heathy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 20, 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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06093542A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.PHASE1 COMPLETED 12 — — Oct 25, 2023Mar 20, 2024Jul 20, 20251 Japan
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Study Endpoints
Primary Endpoints
Number of participants with adverse events
From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)

The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

Secondary Endpoints
Maximum plasma drug concentration (Cmax)
Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD7503EXPERIMENTALParticipants will subcutaneously receive AZD7503.
PlaceboPLACEBO_COMPARATORParticipants will subcutaneously receive placebo.
Interventions
NameTypeDescription
AZD7053DRUGRandomised participants will receive AZD7503 subcutaneously.
PlaceboDRUGRandomised participants will receive placebo subcutaneously.
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For Japanese participants: A Japanese participant is defined as having both parents and 4 Japanese grandparents as confirmed by the interview. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. Participant...

Countries:Japan
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