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AZD7053

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jul 20, 2025

AZD7053 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

AZD7053 clinical trials

AZD7053 · 1 trial · 1 indication

Phase 1 1
NCT06093542A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.Heathy Participants
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
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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 to 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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Frequently asked questions about AZD7053

What is AZD7053?

AZD7053 is an investigational small molecule drug being developed by AstraZeneca PLC. It is in Phase 1 clinical development, and the specific disease or condition it is intended to treat has not been disclosed. It is not approved for any use.

Who is developing AZD7053?

AZD7053 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this small molecule asset.

What phase is AZD7053 in?

AZD7053 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Only early-stage human testing has been conducted so far.

What clinical trials is AZD7053 in?

AZD7053 has been studied in one Phase 1 trial, NCT06093542, titled a study to investigate the safety, tolerability, and pharmacokinetics of AZD7503 in Japanese healthy participants. The trial enrolled 12 healthy volunteers in Japan, was placebo controlled and randomized, and is now completed.

What does AZD7053 target?

The molecular target of AZD7053 has not been disclosed. AstraZeneca has described AZD7053 only as a small molecule in Phase 1 development, without publicly identifying the biological target or pathway it acts on.

Is AZD7053 FDA approved?

No. AZD7053 is an investigational drug in Phase 1 clinical development and is not FDA approved. Its only completed trial, NCT06093542, evaluated safety, tolerability, and pharmacokinetics in 12 healthy Japanese participants rather than testing the drug for a specific disease.