A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants

• Status: Not yet recruiting
• Trial end date: 2023-03-14
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Healthy non smoking male and/or female (of non childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.

• Females must have a negative pregnancy test at screening and on admission to the study centre, must not be lactating and must be of non childbearing potential.

• Body mass index (BMI) between 18 and 30 kg/m^2, inclusive, and weigh at least 60 kg for healthy participants or between 18 and 32 kg/m^2, inclusive, and weigh at least 50 kg for Japanese and Chinese participants.

• For Japanese and Chinese participants:

1. A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes first-, second-and third-generation Japanese whose parents or grandparents are living in a country other than Japan.

2. A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes first-, second-and third-generation Chinese whose parents or grandparents are living in a country other than China.

• Willing to participate in retrospective genotyping analysis for HSD17B13.

Exclusion Criteria:

• History of any clinically important disease or disorder.

• 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 within 4 weeks of administration of study intervention.

• Any laboratory values with the following deviations at screening and/or Day 1:

• Alanine aminotransferase > Upper Limit of Normal (ULN)

• Aspartate aminotransferase > ULN

• Total bilirubin > ULN

• Creatinine > ULN

• White blood cell count < Lower Limit of Normal (LLN)

• Hemoglobin < LLN

• Estimated glomerular filtration rate < 90 mL/min/1.73 m^2

• Platelets >ULN and/or- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results other than those described above, including participants with platelet or bleeding disorders, known platelet dysfunction disorders.

• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or Human Immunodeficiency Virus.

• Confirmed coronavirus disease 2019 (COVID-19) infection during screening and/or admission by polymerase chain reaction (PCR) test.

• Abnormal vital signs, after 5 minutes supine rest

• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.

• Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months.

• History of alcohol abuse or excessive intake of alcohol

• History of Drug abuse or positive screen for drug of abuse or cotinine (nicotine) or alcohol.

• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7503.

• Excessive intake of caffeine containing drinks or food (eg, coffee, tea, chocolate)

• Use of any prescribed or non prescribed medication during the 2 weeks prior to the administration of study intervention or longer if the medication has a long half-life.

• Plasma donation within one month of screening or any blood donation/blood loss more than 500 mL during the 3 months prior to screening.

• Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days (or 5 half lives, whichever is longer) of the administration of study intervention in this study.

• Any ongoing or recent (ie, during the screening period) minor medical complaints.

• Previous bone marrow transplant.

• Non leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.