A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
The goal of this clinical trial is to assess the pharmacokinetic similarity of Biofilgragen, a filgrastim biosimilar, compared with EU-authorized Neupogen after single subcutaneous doses in healthy adult volunteers. The main questions it aims to answer are: * Are the maximum observed serum concentration (Cmax) and area under the serum concentration-time curve from time zero to infinity (AUC0-∞) of filgrastim similar between Biofilgragen and EU-authorized Neupogen? * What is the time to reach maximum observed serum concentration (tmax) and terminal elimination half-life (t½) following administration of each product? Researchers will compare Biofilgragen and EU-authorized Neupogen to assess pharmacokinetic similarity. Participants will: * Receive a single 5 μg/kg subcutaneous dose of Biofilgragen and a single 5 μg/kg subcutaneous dose of EU-Neupogen in a randomized sequence during two treatment periods. * Receive each study product after an overnight fast, with the two treatment periods separated by a minimum 32-day washout period. * Provide blood samples at predefined time points after each dose to measure serum filgrastim concentrations and determine pharmacokinetic parameters. * Undergo safety assessments and monitoring throughout the study, including the follow-up period.
Epistemonikos ID: 473c5de2a384c57a5de970d789aecaa7796f9a55
First added on: Oct 17, 2026