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AZD7053

Phase 1

Heathy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 20, 2025

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

Clinical trial landscape

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 used for?

AZD7053 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, and the available trial focuses on evaluating its safety, tolerability, and pharmacokinetics in Japanese healthy participants.

Who makes AZD7053?

AZD7053 is being developed by AstraZeneca PLC, which is listed on the stock exchange under the ticker AZN.

What phase is AZD7053 in?

AZD7053 is in Phase 1 clinical development. The single completed trial, NCT06093542, was a Phase 1 study. AZD7053 is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD7053 in?

AZD7053 has one completed clinical trial, NCT06093542, titled "A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants." This Phase 1 study enrolled 12 healthy participants in Japan.

Is AZD7053 the same as AZD7503?

AZD7053 is the drug name, but the clinical trial NCT06093542 refers to it as AZD7503. This suggests that AZD7053 and AZD7503 may be alternative names for the same investigational drug, though the relationship is not explicitly confirmed.