Clinical trial NCT02629562: Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Pharmacology
Lead sponsor: Cinfa Biotech
Sponsor class: INDUSTRY
First posted: 2015-12-14
Enrollment: 172
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: PK parameter AUC0-last
timeFrame: 6 weeks
measure: PK parameter Cmax
timeFrame: 6 weeks
measure: PD parameter ANC
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
Study officials:
affiliation: Nuvisan GmbH
name: Michael Lissy, MD
role: PRINCIPAL_INVESTIGATOR
References: