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

NCT07222254 | Active Not Recruiting Phase 1

• 1 other identifier: D7700C00004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Maximum observed drug concentration (Cmax)

  From Day 1 to Extended Follow-up Period (Day 161)

• Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  From Day 1 to Extended Follow-up Period (Day 161)

• Area under concentration-time curve from time 0 to infinity (AUCinf)

  From Day 1 to Extended Follow-up Period (Day 161)

• Number of participants with positive anti-drug antibodies (ADAs) to AZD0292 in serum

  From Day 1 to Extended Follow-up Period (Day 161)

Study Arms (2)

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

AZD0292 DRUG

Single dose of AZD0292 will be administered as an IV infusion.

AZD0292 Dose Level 1; AZD0292 Dose Level 2

Placebo DRUG

Single dose of placebo will be administered as an IV infusion.

AZD0292 Dose Level 1; AZD0292 Dose Level 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Sumida-ku, 130-0004, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2025
• First Posted: October 29, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

JP (1)