A Pilot Study Investigating Bioequivalence Between a Single Dose of Formulation 2 and Formulation 3 of MEDI0382

Exclusion Criteria

• •1. History of, or any existing condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, put the subject at risk, influence the subject's ability to participate, or affect the interpretation of the results of the study
• •2. Impaired renal function, defined as s-creatinine ≥ 130 µmol/L
• •3. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2
• •4. Blood pressure and heart rate in supine position outside the ranges of 90-140 mmHg systolic, 50-90 mmHg diastolic and heart rate 40-100 beats/min following a 10-minute rest period.
• •5. Any clinically significant abnormal ECG, as judged by the investigator
• •6. Active hepatitis B, measured by positive tests of surface antigen HBsAg and/or active hepatitis C, measured by positive hepatitis C virus antibody tests
• •7. Positive human immunodeficiency virus antibodies
• •8. Known or suspected allergy to MEDI0382, any component of the formulation, or related products
• •9. Use of any prescription or nonprescription medication, except for paracetamol, hormonal contraceptives, and vitamins within the last 72 hours prior to check-in
• •10. History of alcoholism or drug abuse during the last 12 months
• •11. Smoking of cigarettes or other tobacco products
• •12. Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the investigator
• •13. Blood donation within the last 3 months
• •14. Participation in any other trial investigating other products or involving blood sampling within the past 30 days
• •15. Potentially noncompliant or uncooperative, as judged by the investigator
• •16. Substance dependence likely to impact subject safety or compliance with study procedures
• •17. Psychiatric illness such that subjects have been committed to an institution by way of official or judicial order
• •18. Involvement of any AstraZeneca, MedImmune, the contract research organization, or the study site employee or their close relatives