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Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02629562
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Cinfa Biotech

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.

Condition or disease Intervention/treatment Phase
Clinical Pharmacology Biological: B12019 and Neulasta Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. PK parameter AUC0-last [ Time Frame: 6 weeks ]
    Area under the plasma concentration-time curve

  2. PK parameter Cmax [ Time Frame: 6 weeks ]
    Maximum observed drug concentration

  3. PD parameter ANC [ Time Frame: 6 weeks ]
    AUEC0-last



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629562


Locations
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Germany
Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Cinfa Biotech
Investigators
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Principal Investigator: Michael Lissy, MD Nuvisan GmbH

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Responsible Party: Cinfa Biotech
ClinicalTrials.gov Identifier: NCT02629562     History of Changes
Other Study ID Numbers: B12019-101
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: July 2016