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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety, Tolerability, Pharmacokinetics, Healthy Participants

In brief

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

Key facts

Study ID

NCT05143905

Run by

AstraZeneca

People needed

56

Starts

2021-12-06

Expected to finish

2022-11-09

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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:
• 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.
• 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.

You may not qualify if…

• 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 < 60 mL/min/1.73 m\^2
• Platelets >ULN and/or <LLN.
• 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.

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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