Trials Sponsors Conditions Drugs Pricing

Conditions

Neutropenia (Low White Blood Cell Count)

Outcome Measures

Primary Outcomes (4)

Maximum observed serum filgrastim concentration (Cmax)
To compare the maximum observed serum filgrastim concentration (Cmax) following administration of Biofilgragen (test product) and EU-authorized Neupogen (reference product). Serum filgrastim concentrations will be measured using a validated enzyme-linked immunosorbent assay (ELISA) from serial blood samples collected at the protocol-specified pharmacokinetic sampling time points. Cmax will be derived using non-compartmental analysis. Pharmacokinetic similarity will be assessed using the two-sided 90% confidence interval for the test-to-reference geometric mean ratio, with acceptance limits of 80% to 125%.
Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period.
Time to reach maximum observed serum filgrastim concentration (tmax) (hours)
To determine the time to reach the maximum observed serum filgrastim concentration (tmax) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be derived from the serum concentration-time profile using non-compartmental analysis and expressed in hours. Results will be summarized descriptively.
Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period.
Area under the serum filgrastim concentration-time curve from time zero to infinity (AUC0-inf)
To compare the area under the serum filgrastim concentration-time curve from time zero extrapolated to infinity (AUC0-inf) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be calculated from serial serum concentration measurements using non-compartmental analysis. Pharmacokinetic similarity will be assessed using the two-sided 90% confidence interval for the test-to-reference geometric mean ratio, with acceptance limits of 80% to 125%.
Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period; AUC extrapolated to infinity.
Terminal elimination half-life of serum filgrastim (t½) (hours)
To determine the terminal elimination half-life (t1/2) of serum filgrastim following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be derived from the serum concentration-time profile using non-compartmental analysis and expressed in hours. Results will be summarized descriptively.
Pre-dose (-0.5 h) and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose, in each treatment period.

Secondary Outcomes (19)

Maximum observed absolute neutrophil count (ANCmax) (cells/µL)
Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period.
Time to maximum observed absolute neutrophil count (time to ANCmax) (hours)
Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period.
Area under the absolute neutrophil count-time curve from time zero to 96 hours (AUEC0-96h)
Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period.
Incidence of treatment-emergent anti-drug antibodies (ADA)
Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days).
Incidence of neutralizing antibodies (NAb)
Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days).

Study Arms (2)

TR

EXPERIMENTAL

Participants randomized to this sequence will receive a single subcutaneous dose of Biofilgragen (Test) during Period 1, followed by a single subcutaneous dose of EU-authorized Neupogen (Reference/active comparator) during Period 2, with the specified washout period between treatments.

Drug: BiofilgragenDrug: Neupogen (filgrastim)

RT

EXPERIMENTAL

Participants randomized to this sequence will receive a single subcutaneous dose of EU-authorized Neupogen (Reference/active comparator) during Period 1, followed by a single subcutaneous dose of Biofilgragen (Test) during Period 2, with the specified washout period between treatments.

Drug: BiofilgragenDrug: Neupogen (filgrastim)

Interventions

BiofilgragenDrug

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.

RTTR

Neupogen (filgrastim)Drug

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Able and willing to provide written, dated informed consent prior to any study specific procedures.
Able to comply with study procedures and visits for the entire study duration.

Sponsors & Collaborators

BioGeneric Pharma
Industrylead

MeSH Terms

Conditions

NeutropeniaLeukopenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

AgranulocytosisCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydrates

Central Study Contacts

Merna Michel

CONTACT

+201220229278 mirna.michael@marc-eg.org

Lydia Bahig

CONTACT

+201225952401

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: A blinded, trained administrator will give the injection. Laboratory and PK/PD/immunogenicity analysts, and the sponsor study team will remain blinded to treatment allocation throughout the study.
Purpose: OTHER
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 4, 2026

First Posted

October 16, 2026

Study Start

December 15, 2026

Estimated

You may not qualify if:

Pregnant or breastfeeding females.
Known hypersensitivity to filgrastim, other G-CSF products, Escherichia coli-derived proteins, or any excipient of the study drugs.
Known latex allergy.
Known history or suspected Hereditary Fructose Intolerance (HFI).
Known history, diagnosis, or screening evidence of clinically significant Sickle Cell Disorder.
Any clinically significant history or presence of cardiovascular, renal, pulmonary, neurological, musculoskeletal, hepatic, gastrointestinal, endocrinological, metabolic or psychiatric disease.
Any clinically significant history or presence of hematologic disease (e.g., leukemia, myelodysplastic syndrome, aplastic anemia, chronic neutropenia, thrombocytopenia, coagulopathy).
History or presence of clinically significant splenomegaly, splenic rupture, or splenectomy at screening.
History or presence of clinically significant respiratory or pulmonary disease (such as moderate-to-severe asthma, COPD, interstitial lung disease, pulmonary hypertension, acute respiratory distress syndrome \[ARDS\], or pulmonary hemorrhage) at screening.
History or presence of clinically significant systemic autoimmune or chronic inflammatory disease (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, or autoimmune thyroid disease requiring systemic therapy).
History of alcohol abuse within 12 months prior to screening.
Smokers who consume more than 10 cigarettes per day (or equivalent nicotine products).
Receipt of any live or live-attenuated vaccine (e.g., MMR, varicella, yellow fever, oral typhoid) within 28 days prior to first study drug administration, or any inactivated, subunit, mRNA, or non-live vaccine (e.g., seasonal influenza, hepatitis A/B, tetanus, COVID-19) within 14 days prior to the first study drug administration.
Positive test results for drugs of abuse screening in urine at screening or before each treatment period.
Positive test results at screening for hepatitis B surface antigen (HBsAg, serum), or combined HIV antigen/antibody (HIV Ag-Ab, serum). Participants with a positive hepatitis C virus antibody (HCV Ab, serum) result will undergo confirmatory PCR testing and may be eligible if the PCR result is negative.
+12 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (19)

Study Arms (2)

TR

RT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (19)

Study Arms (2)

TR

RT

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record