Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MSB11455; Drug: Neulasta

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Herston, Australia, 4006
    • Q-Pharm Pty Ltd
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: First MSB11455 Then Neulasta	Drug: MSB11455; Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.; Drug: Neulasta; Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.; Other Names: pegfilgrastim
EXPERIMENTAL: First Neulasta Then MSB11455	Drug: MSB11455; Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.; Drug: Neulasta; Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.; Other Names: pegfilgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Fresenius Kabi SwissBioSim GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2017
• Primary Completion (ACTUAL): May 8, 2018
• Study Completion (ACTUAL): October 17, 2018

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (ACTUAL): August 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Healthy subjects; MSB11455
• Other Study ID Numbers: EMR200621-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No