Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects

NCT02629562 | Completed Phase 1

• 1 other identifier: B12019-101
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Pharmacology

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

first dosing: single dose of 6mg of B12019 administered subcutaneously, second dosing: single dose of 6mg of Neulasta administered subcutaneously

Biological: B12019 and Neulasta

Arm 2

EXPERIMENTAL

first dosing: single dose of 6mg of Neulasta administered subcutaneously, second dosing: single dose of 6mg of B12019 administered subcutaneously

Biological: B12019 and Neulasta

Interventions

B12019 and Neulasta BIOLOGICAL

GCSF, Growth Colony Stimulating Factor

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cinfa Biotech: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Location

MeSH Terms

Interventions

pegfilgrastim

Study Officials

• Michael Lissy, MD

  Nuvisan GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Last Updated: October 13, 2017

Record last verified: 2016-07

Locations

DE (1)