A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

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 the first administration of IMP.
• - Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization.
• - SARS-CoV-2 second vaccination within 10 days of screening.
• - Confirmed Coronavirus disease 2019 (COVID-19) infection during screening and admission, by Polymerase Chain Reaction (PCR) test (in the London EPCU, COVID-19 infection before or during Screening and/or admission will be confirmed by a COVID-19 test. Subjects will undergo COVID-19 testing prior to ICF signing and any subject testing positive will not be screened for the study).
• - Any clinically important abnormalities in clinical chemistry, coagulation, hematology, or urinalysis results.
• - Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, and Human immunodeficiency virus (HIV).
• - Abnormal vital signs after 10 minutes supine rest at the Screening Visit and on admission to the study center.
• - Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG that may interfere with the interpretation of ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) corrected for heart rate (QTc)
• interval changes including abnormal ST-T-wave morphology at the Screening Visit and/or on admission to the study center.
• - Known or suspected history of drug abuse.
• - Current smokers or those who have smoked or used nicotine products within the previous 3 months.
• - History of alcohol abuse or excessive intake of alcohol.
• - Positive screen for drugs of abuse, cotinine (nicotine), or alcohol at Screening and/or admission to the study center.
• - 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 AZD0780.
• - Excessive intake of caffeine-containing drinks or food.
• - Use of drugs with enzyme inducing properties such as St John’s Wort within 3 weeks prior to the first administration of IMP.
• - Use of any prescribed or nonprescribed medication including antacids, analgesics, herbal remedies, mega-dose vitamins, and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
• - Plasma donation within one month of the Screening Visit or any blood donation/blood
• loss during the 3 months prior to the Screening Visit.
• - Has received another new chemical entity within 30 days or 5 half-lives of the first administration of IMP in this study.
• - Subjects who have previously received AZD0780 within 60 days of the first administration of IMP in this study.
• - Involvement of any Astra Zeneca or study center employee or their close relatives.
• - Any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
• - Subjects who are vegans or have medical dietary restrictions.
• - Subjects who cannot communicate reliably with the investigator.
• - Vulnerable subjects.