A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Heathy Participants

Treatments: Drug: Placebo; Drug: AZD7053

Study type: Interventional

Funder types: Industry

Identifiers

NCT06093542

D9230C00005

Details and patient eligibility

About

The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.

Full 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 of:

• A screening period of 28 days.
• Randomization on Day 1.
• A 9-week Treatment Period. Dose 1 will be administered on Day 1. Dose 2 will be administered at the study site on Day 29. Dose 3 will be administered on Day 57.
• A follow-up period of 10 week after last dose of study intervention.
• The total duration of the study will be 23 weeks

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

AZD7503

Experimental group

Description:

Participants will subcutaneously receive AZD7503.

Treatment:

Drug: AZD7053

Placebo

Placebo Comparator group

Description:

Participants will subcutaneously receive placebo.

Treatment:

Drug: Placebo