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Completed

NCT Number: NCT06093542

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

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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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Sumida-ku, 130-0004, Japan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD7053

Drug

Randomised participants will receive AZD7503 subcutaneously.

Placebo

Drug

Randomised participants will receive placebo subcutaneously.

Primary outcomes

  1. Number of participants with adverse events

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

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

Secondary outcomes

  1. Maximum plasma drug concentration (Cmax)

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

    The Cmax after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

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

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

    The AUClast after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

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

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

    The AUCinf after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

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

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

    The AUCtau after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

  5. Amount of analyte excreted into the urine (Ae)

    Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59

    The Ae after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

  6. Fraction of the dose excreted unchanged in urine (Fe)

    Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59

    The Fe after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

  7. Plasma concentration of AZD7503

    Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59

    The plasma concentration after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

  8. Plasma concentration of unconjugated antisense oligonucleotide (ASO)

    Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59

    The plasma concentration of unconjugated ASO at specified timepoints after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 23, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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