Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Study Overview
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Brief Summary
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Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.

Official Title
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Single-dose, Randomised, Double-blind, Two-stage, Two-way Crossover Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Pegfilgrastim (B12019) Versus the Reference Product Neulasta® in Healthy Subjects

Conditions
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Clinical Pharmacology

Intervention / Treatment
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* Biological: B12019 and Neulasta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>first dosing: single dose of 6mg of B12019 administered subcutaneously, second dosing: single dose of 6mg of Neulasta administered subcutaneously | Biological: B12019 and Neulasta<br>* GCSF, Growth Colony Stimulating Factor<br>|
| Experimental: Arm 2<br>first dosing: single dose of 6mg of Neulasta administered subcutaneously, second dosing: single dose of 6mg of B12019 administered subcutaneously | Biological: B12019 and Neulasta<br>* GCSF, Growth Colony Stimulating Factor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameter AUC0-last | Area under the plasma concentration-time curve | 6 weeks | 
| PK parameter Cmax | Maximum observed drug concentration | 6 weeks | 
| PD parameter ANC | AUEC0-last | 6 weeks |