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Completed

NCT Number: NCT03251248

Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MSB11455

Drug

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

Neulasta

Drug

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

Other names: pegfilgrastim

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time Zero (Pre-dose) to Time of Last Quantifiable Concentration AUC(0-last) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  2. Area Under the Concentration-Time Curve From Time Zero (Pre-dose) Extrapolated to Infinity AUC(0-inf) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  3. Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  4. Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  5. Area Under the Effect-Time Curve From Time Zero (Pre-dose) to Last Measured Time (AUE0-t) for (ANC) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

Secondary outcomes

  1. Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  2. Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  3. Terminal rate constant (λz) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  4. Terminal Half-life (t1/2) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  5. Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  6. Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  7. Area Under Effect Curve from zero to 360 hours (AUEC0-360) for ANC of MSB11455 and Neulasta

    Time frame: Pre-dose up to 15 days post-dose

  8. Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)

    Time frame: Day 1 up to a maximum of 15 months

    Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs

Sponsors and collaborators

Lead sponsor

Fresenius Kabi SwissBioSim GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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