臨床研究等提出・公開システム

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.

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Japanese Participants

Hanada Ryuzo

Souseikai Sumida Hospital

1-29-1, Honjo, Sumida-ku, Tokyo

ryuzo-hanada@lta-med.com

Hanada Ryuzo

Souseikai Sumida Hospital

1-29-1, Honjo, Sumida-ku, Tokyo

+81-3-5608-7276

ryuzo-hanada@lta-med.com

Not Recruiting

Dec. 12, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1 Provision of signed and dated, written informed consent prior to any study-specific
procedures, as described in Appendix A3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

2 Healthy Japanese male and female participants aged 18 to 60 years at screening with suitable veins for cannulation or repeated venipuncture.

3 Women of childbearing Potential must have a negative pregnancy test at screening and on admission to the site.

1 History of any clinically important disease or disorder which, in the opinion of the PI, 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.

2 History or presence of gastrointestinal, hepatic, or renal disease, or any other condition
known to interfere with absorption, distribution, metabolism, or excretion of drugs.

3 History of malignancy, other than treated non-melanoma skin cancers or locally-treated cervical cancer, in the previous 5 years.

4 Any clinically important illness, chronic infections (eg, urinary tract infection) or individuals who are at increased risk of infection (eg, surgery, trauma, severe dental disease, or significant infection) within 30 days of screening.

5 Any laboratory values with the following deviations at screening or on admission to the
site. Abnormal values may be repeated once at the discretion of the PI:

(a) ALT 1.5 x ULN or more.

(b) AST 1.5 x ULN or more.

(c) eGFR 80 mL/min/1.73 m2 or less, as calculated using the estimate using the CKD-EPI
2021 equation.

(d) WBC LLN or less, unless judged by the PI not to be out of range.

(e) Hemoglobin LLN or less.

(f) Platelet count LLN or less.

Both

bronchiectasis, colonized with Pseudomonas aeruginosa

Investigational Medicinal Product infusion

- AEs, SAEs, and AESIs.

- Safety laboratory parameters (hematology, clinical chemistry, and urinalysis).

- 12-lead ECG and cardiac rhythm monitoring (12-lead safety ECG).

- Vital signs (BP, pulse rate, body temperature, respiratory rate, and SpO2)

+81-92-281-7701

Nov. 20, 2025

No

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.

none