Status:
COMPLETED
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
Lead Sponsor:
AstraZeneca
Conditions:
Heathy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
Detailed Description
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously. The study will comprise ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Any abnormal laboratory values, clinical chemistry, hematology or urinalysis results, vital signs, Electrocardiography.
- Any clinically significant cardiovascular event.
- Participants with known autoimmune disease or on-treatment with immune-modulatory drugs.
- Any positive result at the Screening Visit for serum Hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency virus.
- Confirmed COVID-19 infection during screening as per local guidelines.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Use of any prescribed or nonprescribed medication.
- 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.
- Participants who have previously received AZD7503 or any investigational drug targeting HSD17B13.
- Vulnerable participants.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06093542
Start Date
October 25 2023
End Date
March 20 2024
Last Update
July 20 2025
Active Locations (1)
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1
Research Site
Sumida-ku, Japan, 130-0004