Clinical Pharmacology
Conditions
Brief summary
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.
Interventions
BIOLOGICALB12019 and Neulasta
GCSF, Growth Colony Stimulating Factor
Sponsors
Cinfa Biotech
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter AUC0-last | 6 weeks | Area under the plasma concentration-time curve |
| PK parameter Cmax | 6 weeks | Maximum observed drug concentration |
| PD parameter ANC | 6 weeks | AUEC0-last |
Countries
Germany
Outcome results
None listed