Pharmacokinetic study of Benralizumab in Healthy Chinese Subjects

Exclusion Criteria

• 1. Any subject with a history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorder that is capable of altering the metabolism or elimination of drugs or that constitutes a risk factor when taking the study medication.
• 2. Any subject with a documented history of disorders of the immune system at any time.
• 3. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy.
• 4. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1.
• 5. Any subject with a clinically significant relevant deviation from normal in physical examination, electrocardiography, or clinical laboratory tests, as determined by the Principal Investigator.
• 6. Any clinical significant findings off Chest x-rays or CT image. If a chest X-ray or CT has not been performed within 6 months prior to screening visit, a chest X-ray must be performed before the IP administration.
• 7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level > the upper limit of normal (ULN).
• 8. Positive result on screening for serum hepatitis B surface antigen, or hepatitis C antibody. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
• 9. Any subject with any condition resulting in an increased eosinophil count at screening.
• 10. Any condition requiring the regular use of any medication.
• 11. Any subject requiring a prescription medication, other than contraceptives. Subjects taking nonprescription medications must be willing and able to refrain from their use during the inpatient period of the study.
• 12. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, systemic corticosteroid for condition other than short course for nasal polyps, or any experimental anti-inflammatory therapy) within 3 months prior to the date informed consent is obtained, and during the study period.
• 13. Receipt of any marketed or investigational biologic (monoclonal or polyclonal antibody) within 4 months or 5 half-lives prior to the date informed consent, is obtained, whichever is longer, and during the study period. E.g. Previous receipt of mepolizumab, reslizumab, dupilumab, or benralizumab.
• 14. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.
• 15. Receipt of live attenuated vaccines 30 days prior to the date of informed consent.
• 16. Any subject with known sensitivity to any constituent of benralizumab or any other IL-5 receptor antagonist. History of anaphylaxis to any biologic therapy.
• 17. Any subject who has participated in any other study of an IP within either 30 days or 5 half-lives (if known) prior to Visit 1, whichever is longer.
• 18. Current evidence of drug abuse or history of drug abuse within 1 year of randomization, and/or positive results of drug screen and alcohol test at screening and at Day -1.
• 19. Subjects who have an average weekly alcohol intake that exceeds 21 units per week or subjects unwilling to stop alcohol consumption for the duration of the study (1 unit=12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
• 20. Smoker of more than 5 cigarettes/day or equivalent use of nicotine products during the previous 3 months from the day of screening.
• 21. Currently pregnant, breastfeeding or lactating women.
• 22. Any subject who plans to undergo elective surgery within 4 weeks before Visit 3 (Day 1) through the end of the study (Day 85).
• 23. Any subject who has donated blood or in any other way had a loss of blood volume greater than 400 mL within 30 days before beginning the study IP administration.
• 24. Any subject who is unwilling to reside in the clinic during the study period or is unwilling to cooperate fully with the Principal Investigator or designee.