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Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

Sponsor
Fresenius Kabi SwissBioSim GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03251248
Collaborator
(none)
294
Enrollment
2
Locations
2
Arms
13.8
Actual Duration (Months)
147
Patients Per Site
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
294 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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
Actual Study Start Date :
Aug 22, 2017
Actual Primary Completion Date :
May 8, 2018
Actual Study Completion Date :
Oct 17, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [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 [Pre-dose up to 15 days post-dose]

    3. Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta [Pre-dose up to 15 days post-dose]

    4. Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta [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 [Pre-dose up to 15 days post-dose]

    Secondary Outcome Measures

    1. Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta [Pre-dose up to 15 days post-dose]

    2. Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta [Pre-dose up to 15 days post-dose]

    3. Terminal rate constant (λz) of MSB11455 and Neulasta [Pre-dose up to 15 days post-dose]

    4. Terminal Half-life (t1/2) of MSB11455 and Neulasta [Pre-dose up to 15 days post-dose]

    5. Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta [Pre-dose up to 15 days post-dose]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nucleus Network Melbourne Victoria Australia 3004
    2 Q-Pharm Pty Ltd Herston Australia 4006

    Sponsors and Collaborators

    • Fresenius Kabi SwissBioSim GmbH

    Investigators

    • Study Director: Radmila Kanceva, MD, PhD, Fresenius Kabi SwissBioSim GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fresenius Kabi SwissBioSim GmbH
    ClinicalTrials.gov Identifier:
    NCT03251248
    Other Study ID Numbers:
    • EMR200621-001
    First Posted:
    Aug 16, 2017
    Last Update Posted:
    Jul 2, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fresenius Kabi SwissBioSim GmbH
    MSB11455
    Healthy subjects

    Study Results

    No Results Posted as of Jul 2, 2019