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NOT YET RECRUITING
NCT07877467
PHASE1

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

Sponsor: BioGeneric Pharma

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomised, Double-blind, Single-Dose, Two-way Crossover Study to Compare the PK and PD, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-12-15

Completion Date

2027-05-21

Last Updated

2026-10-16

Healthy Volunteers

Yes

Interventions

DRUG

Biofilgragen

Biofilgragen is a filgrastim biosimilar and recombinant human granulocyte colony-stimulating factor (G-CSF). It will be administered as a single subcutaneous injection at a dose of 5 mcg/kg. Biofilgragen is intended to mirror the reference product in amino acid sequence, formulation, route of administration, and dosing schedule and to engage the same G-CSF receptor-mediated mechanisms.

DRUG

Neupogen (filgrastim)

Neupogen is the EU-authorized reference medicinal product containing filgrastim. It will be administered as a single subcutaneous injection at a dose of 5 mcg/kg under the same conditions as Biofilgragen. It serves as the active comparator for the biosimilar comparison and has well-characterized pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles.