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AZD7503

Phase 1

Safety | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 19, 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 Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05143905A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy ParticipantsPHASE1 COMPLETED 56 — — Dec 6, 2021Nov 9, 2022Feb 19, 20251 United States
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Study Endpoints
Primary Endpoints
Number of participants with Adverse Events (AEs)
Up to Final Follow-up (FU) Visit (Week 10) or Early Termination (ET) (assessed up to 14 Weeks)

To assess adverse events as a variable of safety and tolerability of AZD7503 following SC single dose administration.

Secondary Endpoints
Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD7503
(Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD7503
(Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Maximum observed plasma (peak) drug concentration (Cmax) of AZD7503
(Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: AZD7503 dose 1EXPERIMENTALRandomised healthy participants will receive a single dose 1 of AZD7503.
Cohort 2: AZD7503 dose 2EXPERIMENTALRandomised healthy participants will receive a single dose 2 of AZD7503.
Cohort 3: AZD7503 dose 3EXPERIMENTALRandomised healthy participants will receive a single dose 3 of AZD7503.
Cohort 4: AZD7503 dose 4EXPERIMENTALRandomised healthy participants will receive a single dose 4 of AZD7503.
Cohort 5 : AZD7503 dose XEXPERIMENTALRandomised healthy participants will receive a single dose X of AZD7503.
Cohort 6: AZD7503 dose YEXPERIMENTALRandomised healthy participants will receive a single dose Y of AZD7503.
Pooled Placebo for AZD7503 (Cohorts 1 to 6)PLACEBO_COMPARATORRandomised healthy participants will receive placebo.
Japanese Cohort 1: AZD7503 dose 3EXPERIMENTALRandomised healthy Japanese participants will receive a single dose 3 of AZD7503.
Japanese Cohort 2: AZD7503 dose 4EXPERIMENTALRandomised healthy Japanese participants will receive a single dose 4 of AZD7503.
Placebo (Japanese Cohorts)PLACEBO_COMPARATORRandomised healthy Japanese participants will receive placebo.
Chinese Cohort: AZD7503 dose 4EXPERIMENTALRandomised healthy Chinese participants will receive a single dose 4 of AZD7503.
Placebo (Chinese Cohort)PLACEBO_COMPARATORRandomised healthy Chinese participants will receive placebo.
Interventions
NameTypeDescription
AZD7503DRUGRandomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y).
PlaceboDRUGRandomised participants will receive placebo by SC injection
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy non smoking male and/or female (of non childbearing potential) participants with suitable veins for cannulation or repeated venipuncture. * Females must have a negative pregnancy test at screening and on admission to the study centre, must not be lactating and must be ...

Countries:United States
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