A study to evaluate the biosimilarity of SBS6002 to Neulasta when administered to healthy participants

INTERVENTION: Participants will be randomized to one of two possible sequences: Sequence 1: Single dose of 6 mg of SBS6002 (0.6 mL of 10 mg/mL pegfilgrastim solution, based on protein content only) via subcutaneous injection administered on the abdomen, followed by a washout period (of at least 42 days since dose of SBS6002), and a single dose of 6 mg of comparator via subcutaneous injection administered on the abdomen. Sequence 2: Single dose of 6 mg of comparator via subcutaneous injection administered on the abdomen, followed by a washout period (of at least 42 days since dose of comparator), and a single dose of 6 mg of SBS6002 (0.6 mL of 10 mg/mL pegfilgrastim solution, based on protein content only) via subcutaneous injection administered on the abdomen. CONDITION: Inflammatory and Immune System ‐ Normal development and function of the immune system Neutropenia; ; Neutropenia PRIMARY OUTCOME: To assess PD parameters for Absolute Neutrophil Count (ANC) determination after a single 6 mg dose of SBS6002 is administered to healthy volunteer subjects. PD parameters for ANC determination are to include AUEC(0‐t), E(max) and T(max,E).[15 blood samples will be drawn for ANC determination at: pre‐dose, 4, 8, 16, 24, 48, 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), 216 (Day 10), 264 (Day 12), and 336 (Day 15), 504 (Day 22), and 672 (Day 29) hours post‐dose.] To assess PD parameters for CD34+ determination after a single 6 mg dose of SBS6002 is administered to healthy volunteer subjects. PD parameters for CD34+ determination are to include AUEC(0‐t), E(max) and T(max,E).[12 blood samples will be drawn for CD34+ determination at: pre‐dose, 24, 48, 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), 216 (Day 10), 264 (Day 12), 336 (Day 15), 504 (Day 22), and 672 (Day 29) hours post‐dose.] To determine PK parameters after a single 6 mg dose of SBS6002 is administered to healthy volunteer subjects. PK parameters determined are to include C(max), AUC(0‐t), AUC(0‐inf), Residual area, T(max), T(1/2 el), K(el), CL/F, and V(d)/F.[18 blood samples will be drawn for PK analysis during the treatment period at: pre‐dose, 1, 2, 4, 8, 12, 16, 20, 24, 36, 48, 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), 216 (Day 10), 264 (Day 12), and 336 (Day 15) hours post‐dose.] SECONDARY OUTCOME: Primary outcome [4] ; To assess the safety and tolerability after a single 6 mg dose of SBS6002 is administered to healthy volunteer subjects. Safety and tolerability will be assessed by observation of the incidence, severity, causality and seriousness of adverse events (related side effects may include fever, diarrhea, shortness of breath, rash, hair loss, numbness, nosebleeds, headache, and pain); vital signs (blood pressure, heart rate, and oral temperature); laboratory tests (drug and alcohol screening, hematology and coagulation, and biochemistry); injection site evaluation; and medical surveillance by clinical site staff.[Primary timepoint [4] ; Safety and tolerability information will be recorded from the first date of admission to the study unit for a period of 42 days following administration of the last study drug in the assigned sequence. Participant assessments will be taken at the screening visit, as well as during participant confinement to the clinical site (Day ‐1 to Day 3), and on follow‐up visits on Days 4, 5, 6, 8, 10, 12, 15, 22 and 29.] Primary outcome [5] ; To assess immunogenicity via anti‐drug antibody (ADA) titre in blood test after a single 6 mg dose of SBS6002 is administered to healthy volunteer subjects. [Primary timepoint [5] 1) Male, non‐smoker or social smoker. 2) Healthy as defined by: a) the absence of clinically significant illness and surgery within 4 weeks prior to dosing. Inclusion pre‐dosing is at the discretion of the Investigator. ; 3 blood samples will be drawn for anti‐drug antibody (ADA) detection at: pre‐dose, Day 8, and Day 29 post‐dose.] To assess immunogenicity via anti‐drug antibody (ADA) after a single 6 mg dose of Neulasta® is administered to healthy volunteer subjects. [3 blood samples will be drawn for anti‐drug antibody (ADA) detection at: pre‐dose, Day 8, and Day 29 post‐dose.] To assess PD parameters for Absolute Neutrophil Count (ANC) determination after a single 6 mg dose of Neulasta® is administered to healthy volunteer subjects. PD parameters for ANC determination are to include AUEC(0‐t), E(max) and T(max,E).[15 blood samples will be drawn for ANC determination at: pre‐dose, 4, 8, 16, 24, 48, 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), 216 (Day 10), 264 (Day 12), and 336 (Day 15), 504 (Day 22), and 672 (Day 29) hours post‐dose.] To assess PD parameters for CD34+ determination after a single 6 mg dose of Neulasta® is administered to healthy volunteer subjects. PD parameters for CD34+ determination are to include AUEC(0‐t), E(max) and T(max,E).[12 blood samples will be drawn for CD34+ determination at: pre‐dose, 24, 48, 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), 216 (Day 10), 264 (Day 12), 336 (Day 15), 504 (Day 22), and 672 (Day 29) hours post‐dose.] To assess the safety and tolerability after a single 6 mg dose of Neulasta® is administered to healthy volunteer subjects. Safety and tolerability will be assessed by observation of the incidence, severity, causality and seriousness of adverse events (related side effects may include fever, diarrhea, shortness of breath, rash, hair loss, numbness, nosebleeds, headache, and pain); vital signs (blood pressure, heart rate, and oral temperature); laboratory tests (drug and alcohol screening, hematology and coagulation, and biochemistry); injection site evaluation; and medical surveillance by clinical site staff.[Safety and tolerability information will be recorded from the first date of admission to the study unit for a period of 42 days following administration of the last study drug in the assigned sequence. Participant assessments will be taken at the screening visit, as well as during participant confinement to the clinical site (Day ‐1 to Day 3), and on follow‐up visits on Days 4, 5, 6, 8, 10, 12, 15, 22 and 29.] To determine PK parameters after a single 6 mg dose of Neulasta® is administered to healthy volunteer subjects. PK parameters determined are to include C(max), AUC(0‐t), AUC(0‐inf), Residual area, T(max), T(1/2 el), K(el), CL/F, and V(d)/F.[18 blood samples will be drawn for PK analysis during the treatment period at: pre‐dose, 1, 2, 4, 8, 12, 16, 20, 24, 36, 48, 72 (Day 4), 96 (Day 5), 120 (Day 6), 168 (Day 8), 216 (Day 10), 264 (Day 12), and 336 (Day 15) hours post‐dose.] INCLUSION CRITERIA: Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types. Subjects must meet all of the following criteria to be included in the study: b) the absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. c) absence of febrile or infectious illness within 1 week prior to dosing. 3) Provide signed written informed consent prior to the initiation of any study‐specific procedures. 4) Willing and able to comply with the requirements of the protocol and be available for the planned duration of the trial.