A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZ… (NCT07222254) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
Japan18 participantsStarted 2025-12-12
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 wit…
What they're measuring
1
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)
Timeframe: Up to Extended Follow-up Period (Day 161)