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The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First MSB11455 Then Neulasta | Experimental |
| |
| First Neulasta Then MSB11455 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSB11455 | Drug | Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose | |
| Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose | |
| Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose | |
| Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose | |
| Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radmila Kanceva, MD, PhD | Fresenius Kabi SwissBioSim GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | 3004 | Australia | ||
| Q-Pharm Pty Ltd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32660769 | Derived | Lickliter J, Kanceva R, Vincent E, Schueler A, Harrison-Moench E, Yue CS, Stahl M, Ullmann M, Ghori V, Griffin P. Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial. Clin Ther. 2020 Aug;42(8):1508-1518.e1. doi: 10.1016/j.clinthera.2020.05.020. Epub 2020 Jul 11. |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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| Neulasta | Drug | Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1. |
|
|
| Terminal rate constant (λz) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
| Terminal Half-life (t1/2) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
| Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
| Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
| Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta | Pre-dose up to 15 days post-dose |
| Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs) | Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs | Day 1 up to a maximum of 15 months |
| Herston |
| 4006 |
| Australia |