Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Pharmacology
• Intervention / Treatment: Biological: B12019 and Neulasta

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Neu-Ulm, Germany, 89231
    • Nuvisan GmBH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; first dosing: single dose of 6mg of B12019 administered subcutaneously, second dosing: single dose of 6mg of Neulasta administered subcutaneously	Biological: B12019 and Neulasta; GCSF, Growth Colony Stimulating Factor
EXPERIMENTAL: Arm 2; first dosing: single dose of 6mg of Neulasta administered subcutaneously, second dosing: single dose of 6mg of B12019 administered subcutaneously	Biological: B12019 and Neulasta; GCSF, Growth Colony Stimulating Factor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cinfa Biotech
• Investigators: Principal Investigator: Michael Lissy, MD, Nuvisan GmBH

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (ESTIMATE): December 14, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: B12019-101