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| ID | Type | Description | Link |
|---|---|---|---|
| FILGRASTIM IMMUNOGENICITY US | Other Identifier | Alias Study Number | |
| COMPARATIVE IMMUNOGENICITY | Other Identifier | Alias Study Number |
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This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two study periods. In addition, safety assessments will be conducted throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgrastim Hospira | Experimental |
| |
| US-Approved Neupogen | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgrastim Hospira | Biological | 5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a negative baseline anti-drug antibody (ADA) test result and confirmed post-dose positive ADA test result at any time during the study. | 62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a negative baseline ADA test result and post-dose positive neutralizing antibody result at any time during the study; | 62 days (Period 1 Day 0 through Period 2 Day 31 or Final Visit) |
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Inclusion Criteria:
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Healthy male or female volunteers between 18 and 65 years of age (both inclusive).
Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not < 50 kg or >95 kg.
Subjects have abstained from the use of tobacco- or nicotine-containing products for at least 90 days prior to dosing and have a negative urine screen for cotinine at Screening.
Agrees to abstain from alcohol consumption for at least 48 hours prior to Day 1 of dosing in each study period and throughout the 5 days of study treatment and has a negative urine screen for alcohol at Screening.
Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
Exclusion Criteria:
Subjects with any of the following characteristics/conditions will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SeaView Research, Inc. | Coral Gables | Florida | 33134 | United States | ||
| Seaview Jacksonville LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30900158 | Derived | Yao HM, Ottery FD, Borema T, Harris S, Levy J, May TB, Moosavi S, Zhang J, Summers M. PF-06881893 (Nivestym), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(R)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. BioDrugs. 2019 Apr;33(2):207-220. doi: 10.1007/s40259-019-00343-8. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| US-Approved Neupogen | Biological | 5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2. |
|
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| SeaView Research, Inc. | Miami | Florida | 33126 | United States |
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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