Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

Clinical Pharmacology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629562
• Other study ID #: B12019-101
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2015
• Last updated: October 12, 2017
• Start date: November 2015

Study information

• Verified date: July 2016
• Source: Cinfa Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Pharmacology

Intervention

Biological:
• B12019 and Neulasta
GCSF, Growth Colony Stimulating Factor

Locations

Country	Name	City	State
Germany	Nuvisan GmbH	Neu-Ulm

Sponsors (1)

Lead Sponsor	Collaborator
Cinfa Biotech

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter AUC0-last	Area under the plasma concentration-time curve	6 weeks
Primary	PK parameter Cmax	Maximum observed drug concentration	6 weeks
Primary	PD parameter ANC	AUEC0-last	6 weeks