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AZD7503

Phase 1

Safety | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 19, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

AZD7503 · 1 trial · 4 indications

Phase 1 1
NCT05143905A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy ParticipantsSafety
COMPLETED56 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
SafetyUnlock trial analytics

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 to 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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Frequently asked questions about AZD7503

What is AZD7503 used for?

AZD7503 is an investigational small molecule being studied for safety, tolerability, and pharmacokinetics in healthy participants. It is currently in Phase 1 clinical development and is not approved for any medical use.

Who makes AZD7503?

AZD7503 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is AZD7503 in?

AZD7503 is in Phase 1 clinical development. A Phase 1 study assessing its safety, tolerability, and pharmacokinetics in healthy participants has been completed.

What clinical trials is AZD7503 in?

AZD7503 has one completed Phase 1 clinical trial, identified as NCT05143905. This study assessed the safety, tolerability, and pharmacokinetics of AZD7503 in healthy participants in the United States.

Is AZD7503 FDA approved?

AZD7503 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it remains in clinical development and has not been approved for any use.