Neutropenia (Low White Blood Cell Count)Phase 1FIL-BIO-IMGNCT07877467
A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers
A Phase 1 study testing Biofilgragen and Neupogen (filgrastim) in people with Neutropenia (Low White Blood Cell Count), run by BioGeneric Pharma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neutropenia (Low White Blood Cell Count)
- What is being tested?
- Biofilgragen and Neupogen (filgrastim)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2026to 21 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Male or female, 18 to 55 years of age at the time of signing the informed consent.
- BMI between 18.0 and 30.0 kg/m².
- Body weight 50-110 kg.
- 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.
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- 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.
- 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.
- Female participants of non childbearing potential must be either post menopausal (≥12 consecutive months of amenorrhea) or surgically sterile.
Who cannot join
- 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.
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- 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.
- Positive pregnancy test for females of childbearing potential at screening or before each treatment period.
- Whole blood donation more than 400 mL or significant acute blood loss within 8 weeks prior to screening.
- Plasma, platelet, or apheresis donation within 4 weeks prior to screening.
- 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.
- Prior use of erythropoiesis-stimulating agents within 3 months prior to the first study drug administration.
- Use of systemic corticosteroids or other immunosuppressants within 30 days prior to the first study drug administration.
- 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.
- Prior use of cytotoxic or antimetabolite agents within 30 days prior to the first study drug administration.
- 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
- 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.
- 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.
- Any other condition or circumstance that, in the Investigator's medical judgment, renders the participant unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- Neutropenia (Low White Blood Cell Count)
- Being tested
- Biofilgragen, Neupogen (filgrastim)
- Medical subject headings
- Neutropenia, Leukopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Neupogen (filgrastim)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Biofilgragen; Drug: 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. Receives: Drug: Biofilgragen; Drug: Neupogen (filgrastim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days).
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.
Measured: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).
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.
Measured: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).
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.
Measured: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).
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.
Measured: Screening, Treatment Periods 1 and 2, and at the final Follow-up visit (Day 69 + 7 days).
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.
Measured: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
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.
Measured: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
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.
Measured: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
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.
Measured: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
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.
Measured: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
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.
Measured: Screening and at the final Follow-up visit (Day 69 + 7 days).
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.
Measured: Screening and at the final Follow-up visit (Day 69 + 7 days).
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.
Measured: Screening, within 7 days prior to dosing in Treatment Period 2 and at the final Follow-up visit (Day 69 + 7 days).
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:
- Hematology: Hemoglobin, Hematocrit, MCH, MCHC, MCV, RBC, Platelet Count, WBC Count, and Differential WBCs.
- Renal Function: Urea, Creatinine, BUN, and Uric Acid.
- Electrolytes: Sodium and Potassium.
- Liver Function: GGT, ALT, AST, Bilirubin, Alkaline Phosphatase, Total Bilirubin, and Direct Bilirubin.
- Bone and Protein Metabolism: Calcium, Total Protein, and Albumin.
- Other Laboratory Parameters: Random Blood Glucose, Cholesterol, FT4, and TSH.
- 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.
Measured: Screening, within 7 days prior to dosing in Treatment Period 2 and at the final Follow-up visit (Day 69 + 7 days).
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion7 Apr 2027 (estimated)
- Study completion21 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenia (Low White Blood Cell Count)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double blind, single dose, 2 sequence, 2 period (two way crossover) trial in healthy volunteers, conducted as a biosimilarity type PK comparison (within participant design).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGeneric Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877467
- Sponsor's protocol ID
- FIL-BIO-IMG12122025
- Acronym
- FIL-BIO-IMG
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07877467
- Acronym / sponsor ID
- FIL-BIO-IMG / FIL-BIO-IMG12122025
- Conditions
- Neutropenia (Low White Blood Cell Count)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BioGeneric PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 21 May 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, single dose, 2 sequence, 2 period (two way crossover) trial in healthy volunteers, conducted as a biosimilarity type PK comparison (within participant design).
| Arm | Type | Receives |
|---|---|---|
| TR | Experimental | Drug: Biofilgragen, Drug: Neupogen (filgrastim)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. |
| RT | Experimental | Drug: Biofilgragen, Drug: Neupogen (filgrastim)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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- Male or female, 18 to 55 years of age at the time of signing the informed consent.
- BMI between 18.0 and 30.0 kg/m².
- Body weight 50-110 kg.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofilgragenBiofilgragen 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 | RT, TR |
| 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. | Drug | RT, TR |
Primary outcome
Maximum observed serum filgrastim concentration (Cmax)
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.
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 to reach maximum observed serum filgrastim concentration (tmax) (hours)
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.
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.
Area under the serum filgrastim concentration-time curve from time zero to infinity (AUC0-inf)
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.
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%.
Terminal elimination half-life of serum filgrastim (t½) (hours)
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.
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.
19 secondary outcomes
Maximum observed absolute neutrophil count (ANCmax) (cells/µL)
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.
Time to maximum observed absolute neutrophil count (time to ANCmax) (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.
Area under the absolute neutrophil count-time curve from time zero to 96 hours (AUEC0-96h)
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.
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: 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)
Time frame: Predose in Treatment Period 1 (baseline), predose in Treatment Period 2, and at the final Follow-up visit (Day 69 + 7 days).
Incidence, severity, and relationship to study treatment of adverse events (AEs)
Time frame: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).
Incidence, severity, and relationship to study treatment of serious adverse events (SAEs)
Time frame: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).
Incidence of adverse events of special interest (AESIs)
Time frame: From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days).
Physical examination findings
Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up visit (Day 69 + 7 days).
Change in Systolic Blood Pressure from Baseline (mmHg)
Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
Change in Diastolic Blood Pressure from Baseline (mmHg)
Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
Change in Heart Rate from Baseline (beats/minute)
Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
Change in Respiratory Rate from Baseline (breaths/minute)
Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
Change in Body Temperature from Baseline (°C)
Time frame: Screening, Treatment Periods 1 and 2, and at the final Follow-up (Day 69 + 7 days).
12-lead resting electrocardiogram (ECG) findings
Time frame: Screening and at the final Follow-up visit (Day 69 + 7 days).
Chest X-Ray Findings
Time frame: Screening and at the final Follow-up visit (Day 69 + 7 days).
Abdominal ultrasound findings, including spleen assessment
Time frame: Screening, within 7 days prior to dosing in Treatment Period 2 and at the final Follow-up visit (Day 69 + 7 days).
Changes in Clinical Laboratory Parameters from Baseline
Time frame: Screening, within 7 days prior to dosing in Treatment Period 2 and at the final Follow-up visit (Day 69 + 7 days).
Local tolerability at injection site
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biofilgragen and Neupogen (filgrastim) in people with Neutropenia (Low White Blood Cell Count), run by BioGeneric Pharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merna Michel (+201220229278, mirna.michael@marc-eg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed serum filgrastim concentration (Cmax) (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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.