Clinical trials: Granulocyte Colony-Stimulating Factor
- Condition Granulocyte Colony-Stimulating Factor
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
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
Arthritis, Rheumatoid
Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
This exploratory study aims to assess exposure of healthy subjects to systemic challenge with either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular activation markers both in circulation and in…
- Trial name
- NCT03306589
- Testing
- Cantharidin, Lipopolysaccharide, Granulocyte-Macrophage Colony-Stimulating Factor
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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 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 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 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
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.
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 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 Adult Subjects
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when…
- Trial name
- NCT03794180
- Testing
- TJ003234
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- I-Mab Biopharma US Limited
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 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
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
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.