Status:
RECRUITING
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 participa...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 22 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07222254
Start Date
December 12 2025
End Date
July 22 2026
Last Update
December 23 2025
Active Locations (1)
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1
Research Site
Sumida-ku, Japan, 130-0004