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Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

NCT ID: NCT03251248

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-10-17

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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First MSB11455 Then Neulasta

Group Type EXPERIMENTAL

MSB11455

Intervention Type DRUG

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

Neulasta

Intervention Type DRUG

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

First Neulasta Then MSB11455

Group Type EXPERIMENTAL

MSB11455

Intervention Type DRUG

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

Neulasta

Intervention Type DRUG

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

Interventions

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MSB11455

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

Intervention Type DRUG

Neulasta

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

Intervention Type DRUG

Other Intervention Names

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pegfilgrastim

Eligibility Criteria

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Inclusion Criteria

* Subjects who provide signed and dated written informed consent

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fresenius Kabi SwissBioSim GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Radmila Kanceva, MD, PhD

Role: STUDY_DIRECTOR

Fresenius Kabi SwissBioSim GmbH

Locations

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Nucleus Network

Melbourne, Victoria, Australia

Site Status

Q-Pharm Pty Ltd

Herston, , Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 32660769 (View on PubMed)

Other Identifiers

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EMR200621-001

Identifier Type: -

Identifier Source: org_study_id

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