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| ID | Type | Description | Link |
|---|---|---|---|
| IMM HSP-130 | Other Identifier | Alias Study Number |
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This study compares the immune response to the proposed biosimilar PF-06881894 and the US-approved Neulasta reference product. Subjects will receive 2 subcutaneous injections (6 milligrams [mg]) either 1 of the 2 study drugs. Subjects will receive the first dose on Day 1 of Period 1 and the second dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two treatment periods. In addition, safety assessments will be conducted throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06881894 | Experimental | PF-06881894 6 mg SC |
|
| US-approved Neulasta | Active Comparator | US-approved Neulasta 6 mg SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06881894 | Biological | pre-filled syringe 6 mg |
| |
| US-approved Neulasta |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and confirmed postdose positive anti-pegfilgrastim antibody test result at any time during the study. | 90 days (through Period 1 Day1 to Period 2 Day 60 or final visit) |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a negative baseline anti-pegfilgrastim antibody test result and postdose positive neutralizing antibody result at any time during the study. | 90 Days (through Period 1 Day 1 to Period 2 Day 60 or final study visit) |
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Inclusion Criteria:
• Healthy males or females between 18 and 65 years of age (both inclusive) with body mass index between 19 and 30 kg/m2, inclusive, and body weight of not <50 kg or >95 kg, will be enrolled in this study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seaview A Quotient Clinical Business | Coral Gables | Florida | 33134 | United States | ||
| Quotient Sciences- Jacksonville, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32524499 | Derived | Moosavi S, Borema T, Ewesuedo R, Harris S, Levy J, May TB, Summers M, Thomas JS, Zhang J, Yao HM. PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (Neulasta(R)): Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. Adv Ther. 2020 Jul;37(7):3370-3391. doi: 10.1007/s12325-020-01387-x. Epub 2020 Jun 10. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| Biological |
pre-filled syringe 6 mg |
|
| Jacksonville |
| Florida |
| 32256 |
| United States |
| Seaview A Quotient Clinical Business | Miami | Florida | 33126 | United States |
| Vince & Associates Clinical Research Inc. | Overland Park | Kansas | 66212 | United States |