Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Exclusion Criteria

• •Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta®
• •Previous exposure to filgrastim or pegfilgrastim
• •History of drug or alcohol abuse
• •Blood donations in the past 3 months prior to study start, or bone marrow or stem cell donor in the past 12 months (first dose)
• •Medical history of haematological disease, including sickle cell disorders
• •Recent infection (within 1 week prior to first dose)
• •Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory or neurological diseases, that in the opinion of the investigator may interfere with the aim of the study
• •Participation in an interventional or Phase I study in the last 3 months or is current a follow-up visit schedule for any study, or has participation in more than three studies of experimental drug products in the past 12 months prior to screening
• •Subjects with ANC values outside the normal laboratory range at screening
• •Use of prescription or over-the-counter drugs including vitamins within 4 weeks of first dosing
• •Abnormalities in ECG
• •Signs of dermatitis or skin abnormalities affecting the administration area and surroundings
• •History of cancer