Clinical trial NCT03251248: Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects
Official title: A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: MSB11455
Healthy subjects
Lead sponsor: Fresenius Kabi SwissBioSim GmbH
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of MSB11455 and Neulasta in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects who provide signed and dated written informed consent
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455, and laboratory test results within predefined ranges
* Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
Secondary outcomes:
measure: Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Terminal rate constant (λz) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Terminal Half-life (t1/2) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta
timeFrame: Pre-dose up to 15 days post-dose
measure: Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
timeFrame: Day 1 up to a maximum of 15 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd
Study officials:
affiliation: Fresenius Kabi SwissBioSim GmbH
name: Radmila Kanceva, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.