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A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Safety, Tolerability, Pharmacokinetics, Healthy Participants
Interventions: AZD7503, Placebo
Countries: United States
This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.
Eligibility overview
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility 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 \< 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. * 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.
Locations (1)
- Glendale, California, United States