Clinical trials: filgrastim
- Drug or intervention filgrastim
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy
Biosimilarity Study of Subcutaneous Filgrastim in Healthy Volunteers
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between filgrastim formulation, produced by Megalabs (test product) and Granulokine® (reference product)…
- Trial name
- NCT04958772
- Testing
- Filgrastim Megalabs, Granulokine
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Megalabs
Neutropenia (Low White Blood Cell Count)
A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as…
- Trial name
- NCT02766634
- Testing
- Filgrastim Hospira (US), U.S.-approved Neupogen®
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Neutropenia (Low White Blood Cell Count)
A Study to Compare the Pharmacokinetics, Pharmacodynamics, 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.
- Trial name
- FIL-BIO-IMG (NCT07877467)
- Testing
- Biofilgragen, Neupogen (filgrastim)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- BioGeneric Pharma
Healthy Volunteers
Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects
- Trial name
- TPI-120 (NCT03202927)
- Testing
- PEGFILGRASTIM
- Where
- 2 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Adello Biologics, LLC
Chemotherapy-induced Neutropenia
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
- Trial name
- NCT02643901
- Testing
- GW003
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
Healthy Volunteers
Effects of CSL324 in the Lung After Segmental Challenge
This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in…
- Trial name
- NCT05653713
- Testing
- CSL324
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Healthy Apheresis Donors, Mononuclear (MNC) Cell Donors
An Evaluation of the Spectra Optia CMNC Collection Procedure
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC…
- Trial name
- CMNC (NCT02253160)
- Testing
- Spectra Optia CMNC, COBE Spectra MNC, Granulocyte-colony stimulating factor (G-CSF)
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Neutropenia (Low White Blood Cell Count)
A Research Study To Test How Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given By Subcutaneous Injection (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)
This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as…
- Trial name
- NCT02766647
- Testing
- Filgrastim Hospira (US), US-approved Neupogen®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
Pharmacokinetic / Pharmacodynamic Study Comparing MYL-1401H, EU-sourced Neulasta and US-licensed Neulasta
This is a single center, double-blind, randomized, comparative pharmacokinetic and pharmacodynamic study of MYL-1401H and Neulasta (from EU and US source) in Normal Healthy Volunteers.
- Trial name
- NCT02479646
- Testing
- MYL-1401H, EU-Neulasta, US-Neulasta
- Where
- Netherlands
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- Mylan Inc.
Hematopoietic Stem Cell Mobilization
Non-interventional, Long-term Safety Data Collection of Zarzio® / Filgrastim HEXAL® in Stem Cell Donors
Data collection on the safety and efficacy of Zarzio® / Filgrastim HEXAL® in adult healthy unrelated stem cell donors undergoing peripheral blood progenitor cell mobilization.
- Trial name
- SMART (NCT01766934)
- Where
- 2 sites in Germany
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy Volunteers
Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
Donation of whole blood by healthy volunteers after mobilisation by haematopoietic growth factor (rhu-G-CSF = Granocyte) for biological validation of a cell expansion automaton allowing the simultaneous production of several cell…
- Trial name
- CARDIOSTEM (NCT05594433)
- Testing
- Lenograstim
- Where
- 2 sites in France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CellProthera
Healthy Male Subjects
Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®
Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same active content as Neupogen®. BK0023 is expected to have the same tolerability profile and clinical effects as Neupogen® in controlling…
- Trial name
- NCT01933971
- Testing
- Filgrastim test, Filgrastim reference
- Where
- Switzerland
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Bio-ker S.r.l.
Peripheral Blood Stem Cell Transplantation
KRN125 for Mobilization of Hematopoietic Stem Cells
Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.
- Trial name
- NCT03993639
- Testing
- Pegfilgrastim
- Where
- Japan
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kyowa Kirin Co., Ltd.
Healthy Volunteers
Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors
The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.
- Trial name
- SMART101-HV1 (NCT05118113)
- Testing
- Collection of mobilized hematopoietic stem cells (apheresis products) from healthy volunteers
- Where
- France
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Smart Immune SAS
Miscellaneous Peripheral Blood Cell Abnormalities
Safety and Efficacy of TXA127 and Neupogen to Increase Peripheral Blood Stem Cells (PBSCs)
This is a Phase I Study to be conducted in 18 healthy volunteers. Each will receive daily injections for 5 days of TXA127 alone, or Neupogen alone, or TXA127 plus Neupogen together.
- Trial name
- NCT01543971
- Testing
- TXA127, Neupogen (filgrastim)
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tarix Pharmaceuticals
Neutropenia
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
This study is for healthy participants. This study tests single dose of the research drug HSP-130 against two existing approved drugs United States - approved Neulasta and European Union-approved Neulasta.
- Trial name
- NCT02629289
- Testing
- HSP-130, US-approved Neulasta, EU-approved Neulasta
- Where
- Australia
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hematopoietic Stem Cell Transplantation
NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers
This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d)…
- Trial name
- SNOXA12C101 (NCT01194934)
- Testing
- NOX-A12, Filgrastim, NOX-A12 in combination with Filgrastim
- Where
- Germany
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- TME Pharma AG
Healthy Subjects
Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.
The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a…
- Trial name
- NCT01549301
- Testing
- Filgrastim
- Where
- Brazil
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Azidus Brasil
Healthy Volunteers
Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects
This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration.
- Trial name
- TPI-120 (NCT03206229)
- Testing
- PEG-rhG-CSF, Neulasta (PEG-rhG-CSF)
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Adello Biologics, LLC
Healthy Volunteers
A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.
This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product.
- Trial name
- NCT02923791
- Testing
- Filgrastim Hospira, US-Approved Neupogen
- Where
- 3 sites in United States
- Volunteers
- 256 people, healthy volunteers welcome
- Sponsor
- Pfizer