A Study to Assess the Safety, Tolerability, and Pharmacok... | NCT07222254

Studies
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants

NCT07222254

Sponsor

AstraZeneca

Status

Active, not recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

AZD0292
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2025Actual

Primary Completion Date

Jul 20, 2026Estimated

Completion Date

Jul 20, 2026Estimated

First Submitted Date

Oct 28, 2025

First Submission Date that Met QC Criteria

Oct 28, 2025

First Posted Date

Oct 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2026

Last Update Posted Date

Jun 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.

Detailed Description

This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study in healthy Japanese participants to investigate 2 dose levels of AZD0292. Participants will be randomized to receive either AZD0292 or placebo, proceeding with sentinel cohorts.

The study will comprise:

A Screening Period of maximum 28 days.
A Treatment Period during which participants will be resident at the site from the day before study intervention administration (Day -1) until at least 24 h post-EOI with study intervention; and discharged on Day 2.
A Follow-up Period from Day 3 to Day 16.
An extended Follow-up Period from Day 17 to Day 161.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AZD0292 Dose Level 1	Experimental	Participants will receive AZD0292 (dose level 1) or matching placebo on Day 1.	Drug: AZD0292 Drug: Placebo
AZD0292 Dose Level 2	Experimental	Participants will receive AZD0292 (dose level 2) or matching placebo on Day 1.	Drug: AZD0292 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AZD0292	Drug	Single dose of AZD0292 will be administered as an IV infusion.	AZD0292 Dose Level 1 AZD0292 Dose Level 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)	To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants.	Up to Extended Follow-up Period (Day 161)

Secondary Outcomes

Measure	Description	Time Frame
Maximum observed drug concentration (Cmax)	To characterize the Cmax of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.	From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy Japanese participants with suitable veins for cannulation or repeated venipuncture.
Women of childbearing potential (WOCBP) must have a negative pregnancy test and must not be lactating.
Participants must agree to use an approved method of highly effective contraception as defined in the protocol.
Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 45 kg at screening.

Exclusion Criteria:

History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
History of malignancy, other than treated non-melanoma skin cancers or locally-treated cervical cancer, in the previous 5 years.
Any clinically important illness, chronic infections or individuals who are at increased risk of infection.
History of acquired or inherited immunodeficiency disorders.
History of severe coronavirus disease 2019 (COVID-19) infection requiring hospitalization within the last 12 months or clinical history compatible with ongoing long COVID-19.
Current smokers or those who have smoked or used nicotine products within the previous 6 months prior to screening.
History of alcohol or drug abuse within the past 2 years.
History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0292 and excipients contained in AZD0292.
Known hypersensitivity to antihistamines.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Sumida-ku		130-0004	Japan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Types

Not provided

Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

URL

https://vivli.org/