Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: Neulasta, B12019

• Study Type: Interventional
• Enrollment (Actual): 96
• 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:

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).

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of anti-drug antibodies (ADAs)	Incidence of anti-drug antibodies over time (ADAs)	6 weeks
Absolute Neutrophil count (ANC)	AUEC0-last of ANC	6 weeks

Collaborators and Investigators

• Sponsor: Cinfa Biotech
• Investigators: Principal Investigator: Michael Lissy, MD, Nuvisan GmbH, 89231 Neu-Ulm

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: September 22, 2016
• First Posted (ESTIMATE): September 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: B12019-102