Clinical trials: G-CSF
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
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
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
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
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
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
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 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.
Leucocytosis
Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®
- Trial name
- NCT02762799
- Testing
- Leucostim®, Neupogen®
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy Participants
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of…
- Trial name
- GRANIX (NCT03029000)
- Testing
- Tbo-filgrastim
- Where
- 9 sites in United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Healthy
Phase I/II, Randomized, Double-Blind, Study of the Progenitor Cell Mobilizing Effects of Imprime PGG™ Injection Administered at Varied Dosing Regimens With G-CSF Versus G-CSF Alone
This study is a randomized, placebo-controlled, dose-escalation, single-center study evaluating two different doses of Imprime PGG, each in 7 different dosing regimes.
- Trial name
- NCT00542529
- Testing
- Imprime PGG TM for Injection
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- HiberCell, Inc.
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
Healthy Volunteers
A Study to Evaluate the PK, Safety and Tolerability of GMI-1271 With and Without Filgrastim in Healthy Adult Subjects
Phase 1, open-label, parallel, active-controlled, multiple IV dose, proof of concept study conducted at one study center in the United States (US).
- Trial name
- NCT02703051
- Testing
- GMI-1271, Filgrastim
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- GlycoMimetics Incorporated
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
Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers
A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers
- Trial name
- NCT02725086
- Testing
- Leucostim®, Neupogen®
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
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
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
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.
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
Pharmacokinetics
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
- Trial name
- NCT02205320
- Testing
- DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B
- Where
- United States
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited