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This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHS-1701 | Experimental | CHS-1701 followed by CHS-1701 |
|
| Neulasta | Active Comparator | Neulasta followed by Neulasta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHS-1701 | Drug |
| ||
| Pegfilgrastim (Neulasta) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the immunogenicity of CHS-1701 compared to Neulasta | The primary objective of this study is to assess the immunogenicity of CHS-1701 compared to Neulasta based on the development of neutralizing antibodies (NAB) and the percent difference in ADA response | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Any potential impact of ADA or NAB on the pharmacokinetic (PK) profile of CHS-1701 using standard parameters (AUC, Cmax, ANCmax, or ANC (AUC0-t) | 84 days | |
| Any potential impact of ADA or NAB on pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Finck, MD | Coherus Oncology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research | Overland Park | Kansas | United States | |||
| Medpace |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35034311 | Derived | Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16. |
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|
|
| 84 days |
| Any potential impact of ADA or NAB on safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, and local injection site reactions (ISRs) | 84 days |
| Cincinnati |
| Ohio |
| United States |
| ICON | San Antonio | Texas | United States |
| Spaulding Clinical | West Bend | Wisconsin | United States |
| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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