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

Heathy Participants Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06093542
• Other study ID #: D9230C00005
• Status: Completed
• Phase: Phase 1
• Start date: October 25, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heathy Participants

Intervention

Drug:
• AZD7053
Randomised participants will receive AZD7503 subcutaneously.
• Placebo
Randomised participants will receive placebo subcutaneously.

Locations

Country	Name	City	State
Japan	Research Site	Sumida-ku

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum plasma drug concentration (Cmax)	The Cmax after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Secondary	Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)	The AUClast after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Secondary	Area under plasma concentration-time curve from time 0 to infinity (AUCinf)	The AUCinf after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Secondary	Area under plasma concentration-time curve during a dosing interval (AUCtau)	The AUCtau after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Secondary	Amount of analyte excreted into the urine (Ae)	The Ae after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 58, and Day 59
Secondary	Fraction of the dose excreted unchanged in urine (Fe)	The Fe after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 58, and Day 59
Secondary	Plasma concentration of AZD7503	The plasma concentration after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 58, and Day 59
Secondary	Plasma concentration of unconjugated antisense oligonucleotide (ASO)	The plasma concentration of unconjugated ASO at specified timepoints after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.	Day 1, Day 2, Day 3, Day 58, and Day 59