AZD7798 Safety, Tolerability, and Pharmacokinetics after a single dose administration to healthy subjects

Exclusion Criteria

• - History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study, ie, history of any clinically significant disease suggesting immunodeficiency or abnormal immune function or history or presence of clinically significant gastrointestinal (GI), hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of monoclonal antibodies.
• - Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational Medicinal Product (IMP).
• - Selected laboratory values with deviations.
• - Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results.
• - Any positive result on Screening for Hepatitis B surface antigen (HBsAg), anti-Hepatitis B core (HBc) antibody, anti-Hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV).
• - Abnormal vital signs after 5 minutes supine rest at screening and admission.
• - Any clinically important abnormalities in rhythm, conduction or morphology of the electrocardiogram (ECG) after 10 minutes resting and any clinically important abnormalities in the 12 lead ECG that may interfere with the interpretation of Corrected QT interval (QTc) interval changes, including abnormal ST T wave morphology, particularly primary lead or left ventricular hypertrophy.
• - Known or suspected history of drug abuse in the last 2 years.
• - History of alcohol abuse or excessive intake of alcohol within the last 2 years.
• - Positive screen for drugs of abuse at Screening or admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit prior to the first administration of the IMP.
• - 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 AZD7798.
• - Excessive intake of caffeine containing drinks or food.
• - Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
• - Has received another new chemical entity within 30 days/5 half-lives of the first administration of IMP in this study.
• - Has received another new chemical entity within 3 months of the first administration of IMP in this study.
• - 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 cannot communicate reliably with the Investigator.
• - Vulnerable subjects.