Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Inclusion Criteria: * Healthy male subjects * Age ≥18 and ≤55 years * BMI 22.0 - 28.0 kg/m2 * Non-smokers for at least 6 months prior to study start * General good health, based on a comprehensive medical history and physical examination * Adequate organ function and normal laboratory values (unless the investigator considers an abnormality to be clinically not relevant) * Negative hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) tests at screening * Signed informed consent 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