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

NCT06093542 | Completed Phase 1 FDA Drug

• 1 other identifier: D9230C00005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heathy Participants

Keywords

Non-alcoholic Fatty Liver Disease cirrhosis; N-acetyl galactosamine-conjugated antisense oligonucleotide; HSD17B13 protein

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

  From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)

Secondary Outcomes (8)

• Maximum plasma drug concentration (Cmax)

  Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59

• Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

  Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59

• Area under plasma concentration-time curve from time 0 to infinity (AUCinf)

  Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59

• Area under plasma concentration-time curve during a dosing interval (AUCtau)

  Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59

• Amount of analyte excreted into the urine (Ae)

  Day 1, Day 2, Day 3, Day 58, and Day 59

Study Arms (2)

AZD7503

EXPERIMENTAL

Participants will subcutaneously receive AZD7503.

Drug: AZD7053

Placebo

PLACEBO COMPARATOR

Participants will subcutaneously receive placebo.

Drug: Placebo

Interventions

AZD7053 DRUG

Randomised participants will receive AZD7503 subcutaneously.

AZD7503

Placebo DRUG

Randomised participants will receive placebo subcutaneously.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Sumida-ku, 130-0004, Japan

Location

Related Links

• Redacted\_CSR Synopsis\_D9230C00005

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study is single blind where the study site staff including the investigator will remain blinded during the clinical conduct of a given cohort.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: October 25, 2023
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

JP (1)