Neutropenia
Conditions
Interventions
Repeated single dose of 2 mg study drug delivered by 0.2mL subcutaneous (SC)
injection.
Sponsors
Mylan GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Willingness and able to provide Informed Consent ;2. Gender : male or female;3. Age : 18 - 65 years, inclusive;4. Weight : minimal 60 kg;5. BMI : 19.0 - 30.0 kg/m2, inclusive [Body Mass Index (BMI) (kg/m2)
Exclusion criteria
Exclusion criteria: 1. Mental handicap;2. Any past or concurrent medical conditions potentially increasing the subject*s risks. Examples of these include medical history with evidence of clinically relevant pathology (e.g. sickle cell disease, spleen pathologies, hematologic malignancies, and pulmonary illnesses such as Acute Respiratory Distress Syndrome (ARDS), interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) History of relevant drug and/or food allergies;3. Hypersensitivity to Neulasta® or its constituents (sorbitol E420 and sodium acetate) and/or hypersensitivity to E. coli derived proteins and/or history of previous exposure to PEG-GCSF;4. Subjects with any infections, cough or fever within 1 week prior to study drug administration ;5. Fructose intolerance;6. First grade relatives with haematological malignancy;7. Treatment with non-topical medications (including over the counter medication, and herbal remedies such as St. John*s Wort extract) within 7 days prior to study drug administration, with the exception of hormonal contraceptives, multivitamins, vitamin C, food supplements and a limited amount of acetaminophen, which may be used throughout the study. ;8. Participation in a drug study within 12 weeks prior to study drug administration. ;9. Donation of more than 50 mL of blood within 12 weeks prior to study drug administration. Donation of more than 1.5 litres of blood (for men) / more than 1.0 litres of blood (for women) in the 10 months preceding the start of this study.;10. History of alcohol abuse or drug addiction (including soft drugs like cannabis products);11. Regular intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits);12. Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol);13. Positive screen on Hepatitis B surface antigen (HBsAg), anti-Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus 1/2 antibodies (HIV)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics / Pharmacodynamiek and safety, adverse events, laboratory data, vital signs, ECG and physical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| PK: AUC0-inf, Cmax, Tmax, kel and half waardetijd. PD: (AUC), (Tmax), (CD34+ Cmax). | — |
Countries
Netherlands
Outcome results
None listed