Neutropenia Clinical Trial
Official title:
A Phase 1 Study Assessing The Pharmacodynamic And Pharmacokinetic Equivalence Of HSP-130 With US-approved Neulasta (Registered) And EU-approved Neulasta (Registered) Administered As A Single Subcutaneous Dose To Healthy Volunteers
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.
There will be 25 healthy participants in each of the six sequence groups. A total of 150 participants will be studied in one site in Australia. In addition to the 150 participants included, alternate subjects will be asked to come to the site on the day prior to when dosing is scheduled to begin. There will be 3 treatment options with 3 study dosing periods (1, 2 and 3) and at least 56 days between each treatment. The subject once asked to take part in the study will be assigned by chance (randomized) to one of the sequence groups as mentioned above (1, 2, 3, 4, 5, or 6). ;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02452034 -
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
|
Phase 1 | |
| Not yet recruiting |
NCT02806557 -
Profiling Neutrophil Counts in Patients on Chemotherapy
|
N/A | |
| Not yet recruiting |
NCT01714557 -
Prophylactic Piperacillin/Tazobactam in Hematopoietic Stem Cell Transplantation
|
N/A | |
| Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
| Active, not recruiting |
NCT00020865 -
Levofloxacin Compared With Cefepime in Treating Cancer Patients With Fever and Neutropenia
|
Phase 3 | |
| Completed |
NCT00257790 -
The Tobramycin Study
|
Phase 4 | |
| Completed |
NCT00020371 -
BMS-247550 in Treating Patients With Cancers That Have Not Responded to Previous Therapy
|
Phase 1 | |
| Terminated |
NCT00005787 -
Peripheral Stem Cell Transplantation to Prevent Neutropenia in Patients Receiving Chemotherapy for Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00001533 -
Treatment of T-Large Granular Lymphocyte (T-LGL) Lymphoproliferative Disorders With Cyclosporine
|
Phase 1 | |
| Completed |
NCT05585463 -
Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
|
||
| Not yet recruiting |
NCT02238873 -
Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma
|
Phase 3 | |
| Completed |
NCT01058993 -
AMD 3100 for Treatment of Myelokathexis
|
Phase 1 | |
| Completed |
NCT00771810 -
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
|
Phase 2 | |
| Terminated |
NCT00529282 -
A Study of Ceftobiprole in Patients With Fever and Neutropenia.
|
Phase 3 | |
| Completed |
NCT00770172 -
G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy
|
Phase 3 | |
| Completed |
NCT00771433 -
G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT00030758 -
Filgrastim or Pegfilgrastim in Preventing Neutropenia in Women Receiving Chemotherapy Following Surgery for Breast Cancer
|
Phase 4 | |
| Completed |
NCT00001790 -
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children With Fever and Neutropenia
|
Phase 1 | |
| Completed |
NCT00002693 -
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT04154488 -
A Study of Mavorixafor in Participants With Congenital Neutropenia and Chronic Idiopathic Neutropenia Disorders
|
Phase 1/Phase 2 |