A study to investigate safety, tolerability, and pharmacokinetics of AZD7503 in healthy Japanese participants.

JRCT ID: jRCT2071230075

Registered date:17/10/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: nonalcoholic fatty liver disease
• Date of first enrollment: 25/10/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Each participant is expected to be in the study for approximately 23 weeks, including a Screening Period of up to 4 weeks, a 9 week Treatment Period, and a Follow up Period of 10 weeks. Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via SC injection.

Outcome(s)

Primary Outcome

To investigate the safety and tolerability of AZD7503 following SC administration of multiple doses in healthy Japanese participants.
- AEs and SAEs
- 12-lead safety ECGs, dECGs, and telemetry
- Vital signs (including BP, pulse rate, and body temperature)
- Physical examination
- ISRs
- Clinical laboratory evaluations (haematology, including platelet count, clinical chemistry, and coagulation, renal safety biomarkers, immune activation response, complement activation panel, and urinalysis).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 60age old
• Gender: Both

Include criteria

1 Participants must be 18 to 60 years of age inclusive, at the time of signing the informed consent.

2 Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.

3 Participants who are of Japanese ethnicity
A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.

4 Participants must have suitable veins for cannulation or repeated venepuncture.

5 Body mass index within the range 18 to 32 kg/m2 (inclusive) and weigh at least 50 kg.

6 Males and/or females
Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclude criteria

1 As judged by the investigator, any evidence of any clinically important disease or disorder which, in the investigator's opinion makes it undesirable for the participant to participate in the study.

2 History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.

3 Participants with known autoimmune disease or on-treatment with immune modulatory drugs.

4 Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.

5 Any clinically significant cardiovascular event within last 6 months prior to the Screening Visit.

6 Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results, including participants with platelet or bleeding disorders, and known platelet dysfunction disorders as judged by the investigator.

7 Any positive result at the Screening Visit for serum HBsAg, hepatitis C antibody and HIV.

8 Confirmed COVID-19 infection during screening as per local guidelines.

9 Abnormal vital signs, after 10 minutes supine rest at the Screening Visit and/or Day-1

20 Participation in another clinical study with a study intervention administered in the last 3 months prior to randomisation.

27 Previous randomisation in the present study.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06093542