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Safety and Immunogenicity of MSB11455 in Healthy Participants

Sponsor
Fresenius Kabi SwissBioSim GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03251339
Collaborator
(none)
336
Enrollment
2
Locations
2
Arms
13
Actual Duration (Months)
168
Patients Per Site
12.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
336 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects
Actual Study Start Date :
Aug 21, 2017
Actual Primary Completion Date :
Feb 5, 2018
Actual Study Completion Date :
Sep 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: MSB11455

Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.

Drug: MSB11455
Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.
Experimental: US-Neulasta

Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.

Drug: US-Neulasta
Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
Other Names:
  • pegfilgrastim

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To Assess the Immunogenicity of MSB11455 Compared to Neulasta [From first dose up to end of study (Up to 3 months)]

      Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB)

    Secondary Outcome Measures

    1. 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 1 year]

      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:

    • Participants who provide signed and dated written informed consent.

    • Participants with laboratory test results within predefined ranges.

    • Other protocol defined inclusion criteria could apply.

    Exclusion Criteria:

    • Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.

    • Other protocol defined exclusion criteria could apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Auckland Clinical Studies Ltd Auckland New Zealand 1150
    2 Christchurch Clinical Studies Trust Christchurch New Zealand 8001

    Sponsors and Collaborators

    • Fresenius Kabi SwissBioSim GmbH

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fresenius Kabi SwissBioSim GmbH
    ClinicalTrials.gov Identifier:
    NCT03251339
    Other Study ID Numbers:
    • EMR200621-003
    First Posted:
    Aug 16, 2017
    Last Update Posted:
    Jul 2, 2019
    Last Verified:
    Mar 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
    Healthy Participants
    MSB11455

    Study Results

    No Results Posted as of Jul 2, 2019