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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2024-03-20

Brief Summary

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

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Detailed Description

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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

Conditions

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Heathy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The study is single blind where the study site staff including the investigator will remain blinded during the clinical conduct of a given cohort.

Study Groups

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AZD7503

Participants will subcutaneously receive AZD7503.

Group Type EXPERIMENTAL

AZD7053

Intervention Type DRUG

Randomised participants will receive AZD7503 subcutaneously.

Placebo

Participants will subcutaneously receive placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Randomised participants will receive placebo subcutaneously.

Interventions

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AZD7053

Randomised participants will receive AZD7503 subcutaneously.

Intervention Type DRUG

Placebo

Randomised participants will receive placebo subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes