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Not yet recruitingNCT07877467FIL-BIO-IMGUpdated Oct 20, 2026

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

A Phase 1 interventional study of Biofilgragen and Neupogen (filgrastim) in Neutropenia (Low White Blood Cell Count), sponsored by BioGeneric Pharma. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by BioGeneric Pharma · Phase 1, Interventional, and Other

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Neutropenia (Low White Blood Cell Count)
03

In context

Neutropenia

405 studies on the registry are indexed under Neutropenia; 60 are open to participants now.

This study's planned enrollment of 50 is below the median of 93 across 285 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

BioGeneric Pharma is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Able and willing to provide written, dated informed consent prior to any study specific procedures.
  2. Able to comply with study procedures and visits for the entire study duration.
  3. Male or female, 18 to 55 years of age at the time of signing the informed consent.
  4. BMI between 18.0 and 30.0 kg/m².
  5. Body weight 50-110 kg.
  6. Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, laboratory assessments (biochemistry, hematology, urinalysis), and other screening evaluations, as applicable, with results within reference ranges or judged not clinically significant by the Investigator.
  7. Hematology parameters, including absolute neutrophil count (ANC), hemoglobin, platelet count, and total white blood cell (WBC) count, within the laboratory reference ranges or considered clinically acceptable by the Investigator at screening.
  8. Female participants of childbearing potential must use highly effective contraception (e.g., intrauterine device, hormonal implant, or a combined hormonal contraceptive) starting at least 4 weeks before first dosing and continuing until 4 weeks after the last study drug administration.
  9. Female participants of non childbearing potential must be either post menopausal (≥12 consecutive months of amenorrhea) or surgically sterile.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or breastfeeding females.
  2. Known hypersensitivity to filgrastim, other G-CSF products, Escherichia coli-derived proteins, or any excipient of the study drugs.
  3. Known latex allergy.
  4. Known history or suspected Hereditary Fructose Intolerance (HFI).
  5. Known history, diagnosis, or screening evidence of clinically significant Sickle Cell Disorder.
  6. Any clinically significant history or presence of cardiovascular, renal, pulmonary, neurological, musculoskeletal, hepatic, gastrointestinal, endocrinological, metabolic or psychiatric disease.
  7. Any clinically significant history or presence of hematologic disease (e.g., leukemia, myelodysplastic syndrome, aplastic anemia, chronic neutropenia, thrombocytopenia, coagulopathy).
  8. History or presence of clinically significant splenomegaly, splenic rupture, or splenectomy at screening.
  9. 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.
  10. 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).
  11. History of alcohol abuse within 12 months prior to screening.
  12. Smokers who consume more than 10 cigarettes per day (or equivalent nicotine products).
  13. 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.
  14. Positive test results for drugs of abuse screening in urine at screening or before each treatment period.
  15. 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.
  16. Positive pregnancy test for females of childbearing potential at screening or before each treatment period.
  17. Whole blood donation more than 400 mL or significant acute blood loss within 8 weeks prior to screening.
  18. Plasma, platelet, or apheresis donation within 4 weeks prior to screening.
  19. Prior use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), or other hematopoietic growth factors within 3 months prior to the first study drug administration.
  20. Prior use of erythropoiesis-stimulating agents within 3 months prior to the first study drug administration.
  21. Use of systemic corticosteroids or other immunosuppressants within 30 days prior to the first study drug administration.
  22. Prior use of biological immunomodulators (such as tumor necrosis factor [TNF] inhibitors) within 3 months or 5 elimination half-lives (whichever is longer) prior to the first study drug administration.
  23. Prior use of cytotoxic or antimetabolite agents within 30 days prior to the first study drug administration.
  24. Participation in another interventional clinical trial involving administration of an investigational medicinal product, or receipt of an investigational medicinal product, within 90 days or 5 elimination half-lives (whichever is longer) prior to the first study drug administration
  25. Use of any other prescription or OTC medication, herbal product, vitamin, or dietary supplement that, in the Investigator's judgment, may affect hematopoiesis, immune function, filgrastim pharmacokinetics/pharmacodynamics, or study safety assessments within 14 days or 5 elimination half-lives (whichever is longer) prior to the first study drug administration.
  26. Any psychiatric, cognitive, or other condition that, in the investigator's opinion, could compromise the participant's ability to give truly informed consent, comply with study procedures, or safely complete the study.
  27. Any other condition or circumstance that, in the Investigator's medical judgment, renders the participant unsuitable for participation in the study.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    TR

    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: Biofilgragen · Drug: Neupogen (filgrastim)

  • Experimental
    RT

    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: Biofilgragen · Drug: Neupogen (filgrastim)

Interventions

  • DrugBiofilgragen

    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.

  • DrugNeupogen (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.

06

What researchers measure

Primary outcomes

  1. 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%.

    Time frame: 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.

  2. 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.

    Time frame: 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.

  3. 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%.

    Time frame: 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.

  4. 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.

    Time frame: 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

  1. Maximum observed absolute neutrophil count (ANCmax) (cells/µL)

    To compare the maximum observed absolute neutrophil count (ANCmax) following administration of Biofilgragen and EU-authorized Neupogen. ANC will be measured using a validated automated hematology analyzer, and ANCmax will be derived from serial ANC measurements collected at the protocol-specified pharmacodynamic sampling time points.

    Time frame: Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period.

  2. Time to maximum observed absolute neutrophil count (time to ANCmax) (hours)

    To determine the time to reach the maximum observed absolute neutrophil count (tmax, ANC) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be derived from serial ANC measurements and expressed in hours.

    Time frame: Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period.

  3. Area under the absolute neutrophil count-time curve from time zero to 96 hours (AUEC0-96h)

    To compare the area under the absolute neutrophil count-time curve from time zero to 96 hours post-dose (AUEC0-96h) following administration of Biofilgragen and EU-authorized Neupogen. The parameter will be calculated from serial ANC measurements collected during the 96-hour post-dose assessment period.

    Time frame: Pre-dose (-0.5 h) and 4, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours post-dose, in each treatment period.

  4. Incidence of treatment-emergent anti-drug antibodies (ADA)

    To evaluate the incidence of treatment-emergent anti-drug antibodies (ADA) against filgrastim following administration of Biofilgragen and EU-authorized Neupogen. Treatment-emergent ADA will be defined as a negative baseline ADA result followed by one or more confirmed positive ADA results after treatment. ADA will be assessed using the study-specified validated immunogenicity testing method. Results will be summarized by the number and percentage of participants meeting the definition.

    Time frame: Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days).

  5. Incidence of neutralizing antibodies (NAb)

    To evaluate the incidence of neutralizing antibodies (NAb) against filgrastim following administration of Biofilgragen and EU-authorized Neupogen. NAb testing will be performed for confirmed ADA-positive samples, where applicable, using the study-specified neutralizing antibody assay. Results will be summarized by the number and percentage of participants with detected neutralizing antibodies.

    Time frame: Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days).

  6. Incidence, severity, and relationship to study treatment of adverse events (AEs)

    To evaluate the incidence, severity, and relationship to study treatment of adverse events (AEs) following administration of Biofilgragen and EU-authorized Neupogen. AEs will be recorded, assessed, and classified according to the study protocol, including assessment of severity and relationship to study treatment. Events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 29.0. Results will be summarized by the number and percentage of participants experiencing AEs, with severity and relationship reported as applicable.

    Time frame: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).

  7. Incidence, severity, and relationship to study treatment of serious adverse events (SAEs)

    To evaluate the incidence, severity, and relationship to study treatment of serious adverse events (SAEs) following administration of Biofilgragen and EU-authorized Neupogen. SAEs will be recorded, assessed, and classified according to the study protocol and coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 29.0. Results will be summarized by the number and percentage of participants experiencing SAEs, with severity and relationship to study treatment reported as applicable.

    Time frame: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).

  8. Incidence of adverse events of special interest (AESIs)

    To evaluate the incidence of adverse events of special interest (AESIs), including splenic events, pulmonary events, capillary leak syndrome, vasculitis, glomerulonephritis, and hypersensitivity reactions. AESIs will be recorded and assessed according to the study protocol and coded using the Medical Dictionary for Regulatory Activities (MedDRA), Version 29.0. Results will be summarized by the number and percentage of participants experiencing AESIs.

    Time frame: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).

  9. Physical examination findings

    To assess physical examination findings following the protocol-specified complete physical examination, covering general appearance; head, eyes, ears, nose, and throat; cardiovascular, respiratory, abdominal, musculoskeletal, neurologic, and skin systems. Findings will be documented and clinically significant abnormalities will be evaluated according to the study protocol.

    Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up visit (Day 69 + 7 days).

  10. Change in Systolic Blood Pressure from Baseline (mmHg)

    To evaluate systolic blood pressure following administration of Biofilgragen and EU-authorized Neupogen. Systolic blood pressure will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in millimeters of mercury (mmHg). Changes and clinically significant findings will be assessed according to the study protocol.

    Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).

  11. Change in Diastolic Blood Pressure from Baseline (mmHg)

    To evaluate diastolic blood pressure following administration of Biofilgragen and EU-authorized Neupogen. Diastolic blood pressure will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in millimeters of mercury (mmHg). Changes and clinically significant findings will be assessed according to the study protocol.

    Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).

  12. Change in Heart Rate from Baseline (beats/minute)

    To evaluate heart rate following administration of Biofilgragen and EU-authorized Neupogen. Heart rate will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in beats per minute. Changes and clinically significant findings will be assessed according to the study protocol.

    Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).

  13. Change in Respiratory Rate from Baseline (breaths/minute)

    To evaluate respiratory rate following administration of Biofilgragen and EU-authorized Neupogen. Respiratory rate will be measured using the protocol-specified standardized vital-sign assessment procedure and recorded in breaths per minute. Changes and clinically significant findings will be assessed according to the study protocol.

    Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).

  14. Change in Body Temperature from Baseline (°C)

    To evaluate body temperature following administration of Biofilgragen and EU-authorized Neupogen. Body temperature will be measured using the protocol-specified vital-sign assessment procedure and recorded in degrees Celsius (°C). Changes and clinically significant findings will be assessed according to the study protocol.

    Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).

  15. 12-lead resting electrocardiogram (ECG) findings

    To assess cardiac findings using a 12-lead resting electrocardiogram (ECG) performed according to the study protocol. ECG findings will be reviewed and documented, and clinically significant abnormalities will be evaluated by the Investigator.

    Time frame: Screening and at the final Follow-up visit (Day 69 + 7 days).

  16. Chest X-Ray Findings

    To assess pulmonary findings using chest X-ray examinations performed according to the study protocol. Findings will be reviewed and documented, and clinically significant abnormalities will be evaluated by the Investigator.

    Time frame: Screening and at the final Follow-up visit (Day 69 + 7 days).

  17. Abdominal ultrasound findings, including spleen assessment

    To assess abdominal ultrasound findings, including spleen assessment, using the protocol-specified ultrasonography examination. Findings will be reviewed and documented, and clinically significant abnormalities will be evaluated by the Investigator.

    Time frame: Screening, within 7 days prior to dosing in Treatment Period 2 and at the final Follow-up visit (Day 69 + 7 days).

  18. Changes in Clinical Laboratory Parameters from Baseline

    To evaluate changes in clinical laboratory parameters from baseline following administration of Biofilgragen and EU-authorized Neupogen. Clinical laboratory assessments will include: 1. Hematology: Hemoglobin, Hematocrit, MCH, MCHC, MCV, RBC, Platelet Count, WBC Count, and Differential WBCs. 2. Renal Function: Urea, Creatinine, BUN, and Uric Acid. 3. Electrolytes: Sodium and Potassium. 4. Liver Function: GGT, ALT, AST, Bilirubin, Alkaline Phosphatase, Total Bilirubin, and Direct Bilirubin. 5. Bone and Protein Metabolism: Calcium, Total Protein, and Albumin. 6. Other Laboratory Parameters: Random Blood Glucose, Cholesterol, FT4, and TSH. 7. Urinalysis: Colour, Aspect, pH, Specific Gravity, Glucose, Ketone Bodies, Bilirubin, Urobilinogen, Albumin, Pus Cells, Red Blood Cells, Epithelial Cells, Crystals, Amorphous Materials, Casts, Parasites, and Yeast Cells.

    Time frame: Screening, within 7 days prior to dosing in Treatment Period 2 and at the final Follow-up visit (Day 69 + 7 days).

  19. Local tolerability at injection site

    To evaluate local tolerability at the injection site following administration of Biofilgragen and EU-authorized Neupogen. Injection-site reactions will be assessed and recorded according to the study protocol. Reported injection-site reactions will be followed through the final Follow-up visit.

    Time frame: Following each study treatment administration during both treatment periods, with follow-up of any reported injection-site reactions through the final follow-up visit on Day 69 (±7 days).

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Apr 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2026
First posted
Oct 16, 2026
StartEst.
Dec 15, 2026
Primary completionEst.
Apr 7, 2027
CompletionEst.
May 21, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 2 updates
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: identifiers
  2. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07877467
Lead sponsor
BioGeneric Pharma
Responsible party
Sponsor
First posted
Oct 16, 2026
Start date
Dec 15, 2026 (estimated)
Primary completion
Apr 7, 2027 (estimated)
Completion
May 21, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Merna Michel
Contact
mirna.michael@marc-eg.org
+201220229278
Lydia Bahig
Contact
lydia.bahig@marc-eg.org
+201225952401

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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