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Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02912377
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
Cinfa Biotech

Brief Summary:
Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Neulasta, B12019 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta® in Healthy Subjects
Study Start Date : September 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1; B12019 / Neulasta
2 single doses of B12019 followed by one dose of Neulasta
Biological: Neulasta, B12019
GCSF, Growth Colony Stimulating Factor

Experimental: Arm 2; Neulasta / B12019
2 single doses of Neulasta followed by one dose B12019
Biological: Neulasta, B12019
GCSF, Growth Colony Stimulating Factor

Primary Outcome Measures :
  1. Incidence of anti-drug antibodies (ADAs) [ Time Frame: 6 weeks ]
    Incidence of anti-drug antibodies over time (ADAs)

  2. Absolute Neutrophil count (ANC) [ Time Frame: 6 weeks ]
    AUEC0-last of ANC

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Healthy male subjects, between 18 and 55 years of age (inclusive).
  2. BMI between 20.0 and 30.0 kg/m² (inclusive).
  3. Weight between 60 and 100 kg (inclusive).
  4. Non-smoker for at least 3 months or mild smokers with a consumption of less than 5 cigarettes (or equivalent) per day prior to study start.
  5. Healthy subjects as determined by medical history, physical examination including vital signs, ECG and clinical laboratory testing.
  6. Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol and to participate in the entire trial period.
  7. Subjects who are able and willing to give written informed consent.
  8. Male subject and his female spouse/partner who is of childbearing potential must be using effective contraception starting at screening and continue throughout the clinical study period.
  9. Male subject must not donate sperm starting at screening and throughout the clinical study period and for 3 months after final study drug administration.

Exclusion Criteria:

History of:

  1. Evidence in the subject's medical history or in the medical examination of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, central nervous system diseases or other significant acute or chronic diseases, especially hereditary fructose intolerance, which might influence either the safety of the subject or the absorption, metabolism or excretion of the active agent under investigation.
  2. Subjects with clinically relevant neurologic or psychiatric illness.
  3. Subjects with clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing).
  4. Previous exposure to pegfilgrastim.
  5. Known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim or any other component of B12019 or Neulasta® as listed in section 7.2.
  6. History of allergy to any recombinant protein.
  7. History of cancer.
  8. History of haematological disease, including sickle cell disorder.
  9. History of pulmonary infiltrates or pneumonia within 6 months before the first study drug administration.
  10. Known anti-drug antibodies to filgrastim or pegfilgrastim, including known antibodies to PEG as a consequence of exposure to PEG other than pegfilgrastim (e.g. cosmetics, etc.).
  11. Subjects not willing or able to comply with the food and beverage restrictions (grapefruit/pomelo, starfruit, poppy seeds).

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 identifier (NCT number): NCT02912377

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Nuvisan GmbH
Neu-Ulm, Germany, 89231
Sponsors and Collaborators
Cinfa Biotech
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Principal Investigator: Michael Lissy, MD Nuvisan GmbH, 89231 Neu-Ulm
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Responsible Party: Cinfa Biotech Identifier: NCT02912377    
Other Study ID Numbers: B12019-102
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017