Trial · NCT07877467
A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers
NCT07877467, Phase 1, Not yet recruiting, BioGeneric Pharma
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers. Trials, record NCT07877467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877467
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Tolerability of Filgrastim Biosimilar and Neupogen Reference Product in Healthy Volunteers
- NCT number
- NCT07877467
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 50 participants, estimated
- Lead sponsor
- BioGeneric Pharma
- Conditions
- Neutropenia (Low White Blood Cell Count)
- Interventions
- Biofilgragen, Neupogen (filgrastim)
- First posted
- 2026-10-16
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum observed serum filgrastim concentration (Cmax) | 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%. |
| Primary | Time to reach maximum observed serum filgrastim concentration (tmax) (hours) | 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. |
| Primary | Area under the serum filgrastim concentration-time curve from time zero to infinity (AUC0-inf) | 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%. |
| Primary | Terminal elimination half-life of serum filgrastim (t½) (hours) | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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. | 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. |
| Secondary | 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). | 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. |
| Secondary | 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). | 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. |
| Secondary | Incidence, severity, and relationship to study treatment of adverse events (AEs) | From signing the Informed Consent Form through the final Follow-up visit (Day 69 + 7 days). | 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. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07877467
GET https://conductscience.org/api/trials/v1/NCT07877467/registered?page=2