<br>        Inclusion Criteria:<br><br>          1. Healthy male subjects, between 18 and 55 years of age (inclusive).<br><br>          2. BMI between 20.0 and 30.0 kg/m² (inclusive).<br><br>          3. Weight between 60 and 100 kg (inclusive).<br><br>          4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5<br>             cigarettes (or equivalent) per day prior to study start.<br><br>          5. Healthy subjects as determined by medical history, physical examination including<br>             vital signs, ECG and clinical laboratory testing.<br><br>          6. Able to comply with protocol requirements, including overnight stays, blood sample<br>             collections as defined in the protocol and to participate in the entire trial period.<br><br>          7. Subjects who are able and willing to give written informed consent.<br><br>          8. Male subject and his female spouse/partner who is of childbearing potential must be<br>             using effective contraception starting at screening and continue throughout the<br>             clinical study period.<br><br>          9. Male subject must not donate sperm starting at screening and throughout the clinical<br>             study period and for 3 months after final study drug administration.<br><br>        Exclusion Criteria:<br><br>        History of:<br><br>          1. Evidence in the subject's medical history or in the medical examination of any<br>             clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,<br>             haematological, central nervous system diseases or other significant acute or chronic<br>             diseases, especially hereditary fructose intolerance, which might influence either the<br>             safety of the subject or the absorption, metabolism or excretion of the active agent<br>             under investigation.<br><br>          2. Subjects with clinically relevant neurologic or psychiatric illness.<br><br>          3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,<br>             seasonal allergies at time of dosing).<br><br>          4. Previous exposure to pegfilgrastim.<br><br>          5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim<br>             or any other component of B12019 or Neulasta® as listed in section 7.2.<br><br>          6. History of allergy to any recombinant protein.<br><br>          7. History of cancer.<br><br>          8. History of haematological disease, including sickle cell disorder.<br><br>          9. History of pulmonary infiltrates or pneumonia within 6 months before the first study<br>             drug administration.<br><br>         10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies<br>             to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,<br>             etc.).<br><br>         11. Subjects not willing or able to comply with the food and beverage restrictions<br>             (grapefruit/pomelo, starfruit, poppy seeds).<br>      ;<br>        Inclusion Criteria:<br><br>          1. Healthy male subjects, between 18 and 55 years of age (inclusive).<br><br>          2. BMI between 20.0 and 30.0 kg/m² (inclusive).<br><br>          3. Weight between 60 and 100 kg (inclusive).<br><br>          4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5<br>             cigarettes (or equivalent) per day prior to study start.<br><br>          5. Healthy subjects as determined by medical history, physical examination including<br>             vital signs, ECG and clinical laboratory testing.<br><br>          6. Able to comply with protocol requirements, including overnight stays, blood sample<br>             collections as defined in the protocol and to participate in the entire trial period.<br><br>          7. Subjects who are able and willing to give written informed consent.<br><br>          8. Male subject and his female spouse/partner who is of childbearing potential must be<br>             using effective contraception starting at screening and continue throughout the<br>             clinical study period.<br><br>          9. Male subject must not donate sperm starting at screening and throughout the clinical<br>             study period and for 3 months after final study drug administration.<br><br>        Exclusion Criteria:<br><br>        History of:<br><br>          1. Evidence in the subject's medical history or in the medical examination of any<br>             clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,<br>             haematological, central nervous system diseases or other significant acute or chronic<br>             diseases, especially hereditary fructose intolerance, which might influence either the<br>             safety of the subject or the absorption, metabolism or excretion of the active agent<br>             under investigation.<br><br>          2. Subjects with clinically relevant neurologic or psychiatric illness.<br><br>          3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,<br>             seasonal allergies at time of dosing).<br><br>          4. Previous exposure to pegfilgrastim.<br><br>          5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim<br>             or any other component of B12019 or Neulasta® as listed in section 7.2.<br><br>          6. History of allergy to any recombinant protein.<br><br>          7. History of cancer.<br><br>          8. History of haematological disease, including sickle cell disorder.<br><br>          9. History of pulmonary infiltrates or pneumonia within 6 months before the first study<br>             drug administration.<br><br>         10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies<br>             to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,<br>             etc.).<br><br>         11. Subjects not willing or able to comply with the food and beverage restrictions<br>             (grapefruit/pomelo, starfruit, poppy seeds).<br>      ;<br>        Inclusion Criteria:<br><br>          1. Healthy male subjects, between 18 and 55 years of age (inclusive).<br><br>          2. BMI between 20.0 and 30.0 kg/m² (inclusive).<br><br>          3. Weight between 60 and 100 kg (inclusive).<br><br>          4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5<br>             cigarettes (or equivalent) per day prior to study start.<br><br>          5. Healthy subjects as determined by medical history, physical examination including<br>             vital signs, ECG and clinical laboratory testing.<br><br>          6. Able to comply with protocol requirements, including overnight stays, blood sample<br>             collections as defined in the protocol and to participate in the entire trial period.<br><br>          7. Subjects who are able and willing to give written informed consent.<br><br>          8. Male subject and his female spouse/partner who is of childbearing potential must be<br>             using effective contraception starting at screening and continue throughout the<br>             clinical study period.<br><br>          9. Male subject must not donate sperm starting at screening and throughout the clinical<br>             study period and for 3 months after final study drug administration.<br><br>        Exclusion Criteria:<br><br>        History of:<br><br>          1. Evidence in the subject's medical history or in the medical examination of any<br>             clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,<br>             haematological, central nervous system diseases or other significant acute or chronic<br>             diseases, especially hereditary fructose intolerance, which might influence either the<br>             safety of the subject or the absorption, metabolism or excretion of the active agent<br>             under investigation.<br><br>          2. Subjects with clinically relevant neurologic or psychiatric illness.<br><br>          3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,<br>             seasonal allergies at time of dosing).<br><br>          4. Previous exposure to pegfilgrastim.<br><br>          5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim<br>             or any other component of B12019 or Neulasta® as listed in section 7.2.<br><br>          6. History of allergy to any recombinant protein.<br><br>          7. History of cancer.<br><br>          8. History of haematological disease, including sickle cell disorder.<br><br>          9. History of pulmonary infiltrates or pneumonia within 6 months before the first study<br>             drug administration.<br><br>         10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies<br>             to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,<br>             etc.).<br><br>         11. Subjects not willing or able to comply with the food and beverage restrictions<br>             (grapefruit/pomelo, starfruit, poppy seeds).<br>      ;<br>        Inclusion Criteria:<br><br>          1. Healthy male subjects, between 18 and 55 years of age (inclusive).<br><br>          2. BMI between 20.0 and 30.0 kg/m² (inclusive).<br><br>          3. Weight between 60 and 100 kg (inclusive).<br><br>          4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5<br>             cigarettes (or equivalent) per day prior to study start.<br><br>          5. Healthy subjects as determined by medical history, physical examination including<br>             vital signs, ECG and clinical laboratory testing.<br><br>          6. Able to comply with protocol requirements, including overnight stays, blood sample<br>             collections as defined in the protocol and to participate in the entire trial period.<br><br>          7. Subjects who are able and willing to give written informed consent.<br><br>          8. Male subject and his female spouse/partner who is of childbearing potential must be<br>             using effective contraception starting at screening and continue throughout the<br>             clinical study period.<br><br>          9. Male subject must not donate sperm starting at screening and throughout the clinical<br>             study period and for 3 months after final study drug administration.<br><br>        Exclusion Criteria:<br><br>        History of:<br><br>          1. Evidence in the subject's medical history or in the medical examination of any<br>             clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary,<br>             haematological, central nervous system diseases or other significant acute or chronic<br>             diseases, especially hereditary fructose intolerance, which might influence either the<br>             safety of the subject or the absorption, metabolism or excretion of the active agent<br>             under investigation.<br><br>          2. Subjects with clinically relevant neurologic or psychiatric illness.<br><br>          3. Subjects with clinically relevant allergy (except for untreated, asymptomatic,<br>             seasonal allergies at time of dosing).<br><br>          4. Previous exposure to pegfilgrastim.<br><br>          5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim<br>             or any other component of B12019 or Neulasta® as listed in section 7.2.<br><br>          6. History of allergy to any recombinant protein.<br><br>          7. History of cancer.<br><br>          8. History of haematological disease, including sickle cell disorder.<br><br>          9. History of pulmonary infiltrates or pneumonia within 6 months before the first study<br>             drug administration.<br><br>         10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies<br>             to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics,<br>             etc.).<br><br>         11. Subjects not willing or able to comply with the food and beverage restrictions<br>             (grapefruit/pomelo, starfruit, poppy seeds).<br>