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This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 (Coherus pegfligrastim) or 6mg SC dose of Neulasta (pegfilgrastim) given during each period.
This is a randomized, single-blind, 3-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6mg subcutaneous injection of CHS-1701 or 6mg SC dose of Neulasta given during each period.
The screening period may occur up to 28 days prior to the confinement period. After screening, eligible subjects will be randomly assigned to one of three possible treatment sequences. Treatments will be spaced by not less than 28 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | 3 doses of CHS-1701 or Neulasta, random order |
|
| Sequence B | Experimental | 3 doses of CHS-1701 or Neulasta, random order |
|
| Sequence C | Experimental | 3 doses of CHS-1701 or Neulasta, random order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHS-1701 | Drug |
| ||
| Pegfilgrastim |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence as measured by PK and PD | The primary objective of this study is to assess the bioequivalence of CHS-1701 with Neulasta® based on the pharmacokinetics (PK) of pegfilgrastim and the pharmacodynamic (PD) response as measured by absolute neutrophil count (ANC) | 84 Days |
| Measure | Description | Time Frame |
|---|---|---|
| PK Profile: Cmax | Characterization of the PK profile of CHS-1701 using standard parameters of maximum plasma concentration (Cmax) | 84 Days |
| PK Profile: tmax | Characterization of the PK profile of CHS-1701 using standard parameters of time to maximum plasma concentration (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Finck, MD | Coherus BioSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT | Cypress | California | 90630 | United States | ||
| Medpace CPU |
| 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. | |
| 32789809 | Derived |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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| Drug |
|
|
| 84 Days |
| PK Profile: AUC0-t | Characterization of the PK profile of CHS-1701 using standard parameters of area under the plasma concentration versus time curve calculated from 0 to the last measurable observation (AUC0-t) | 84 Days |
| PK Profile: t1/2 | Characterization of the PK profile of CHS-1701 using standard parameters of terminal elimination half-life (t1/2) | 84 Days |
| Safety Profile as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs) | Characterization of the safety profile and tolerance of CHS-1701, as assessed by clinical adverse events (AEs), laboratory variables, vital signs, incidence of antidrug antibodies (ADAs), and local injection site reactions (ISRs). | 84 Days |
| Cincinnati |
| Ohio |
| 45227 |
| United States |
| ICON | San Antonio | Texas | United States |
| Spaulding | West Bend | Wisconsin | 53095 | United States |
| Finck B, Tang H, Civoli F, Hodge J, O'Kelly H, Vexler V. Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects. Adv Ther. 2020 Oct;37(10):4291-4307. doi: 10.1007/s12325-020-01459-y. Epub 2020 Aug 13. |