NCT03251248

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Aug 2017

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

August 22, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
Last Updated

July 2, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

August 14, 2017

Last Update Submit

June 28, 2019

Conditions

Healthy

Keywords

MSB11455Healthy subjects

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

First MSB11455 Then Neulasta

EXPERIMENTAL
Drug: MSB11455Drug: Neulasta

First Neulasta Then MSB11455

EXPERIMENTAL
Drug: MSB11455Drug: Neulasta

Interventions

MSB11455DRUG

Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.

First MSB11455 Then NeulastaFirst Neulasta Then MSB11455
NeulastaDRUG

Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.

Also known as: pegfilgrastim
First MSB11455 Then NeulastaFirst Neulasta Then MSB11455

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who provide signed and dated written informed consent

You may not qualify if:

  • Subjects who have no known hypersensitivity to any component of Neulasta or MSB11455, and laboratory test results within predefined ranges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Q-Pharm Pty Ltd

Herston, 4006, Australia

Location

Related Publications (1)

  • 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.

    PMID: 32660769DERIVED

MeSH Terms

Interventions

pegfilgrastim

Study Officials

  • Radmila Kanceva, MD, PhD

    Fresenius Kabi SwissBioSim GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2017

First Posted

August 16, 2017

Study Start

August 22, 2017

Primary Completion

May 8, 2018

Study Completion

October 17, 2018

Last Updated

July 2, 2019

Record last verified: 2019-01

Locations

AU(2)