NCT06093542CompletedPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
A Randomised, Single-blind, Single Center, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants.
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 17 Oct 2023
- Start date
- 25 Oct 2023
- Primary completion date
- 20 Mar 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06093542
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 25 Oct 2023 to the primary completion date, 20 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with known autoimmune disease or on-treatment with immune-modulatory drugs.
- Use of any prescribed or nonprescribed medication.
- Participants who have previously received AZD7503 or any investigational drug targeting HSD17B13.
Other illness
- History of any clinically significant disease or disorder in the investigator's opinion.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma.
- Confirmed COVID-19 infection during screening as per local guidelines.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- History of major bleed or high-risk of bleeding diathesis.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
Lab values
- Any abnormal laboratory values, clinical chemistry, hematology or urinalysis results, vital signs, Electrocardiography.
- Any positive result at the Screening Visit for serum Hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency virus.
Other
- Any clinically significant cardiovascular event.
- Vulnerable participants.
Who the study is looking for
- For Japanese participants: A Japanese participant is defined as having both parents and 4 Japanese grandparents as confirmed by the interview. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. Participants must have suitable veins for cannulation.
- Females must be of non-childbearing potential.
- Males and females must adhere to the contraception methods.
- Have a Body mass index between 18 and 30 kg/m2 inclusive.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Sumida-ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.