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Completed

NCT Number: NCT03251339

Safety and Immunogenicity of MSB11455 in Healthy Participants

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

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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

Auckland Clinical Studies Ltd, Auckland, New Zealand

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

MSB11455

Drug

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.

US-Neulasta

Drug

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

Primary outcomes

  1. To Assess the Immunogenicity of MSB11455 Compared to Neulasta

    Time frame: 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 outcomes

  1. 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 1 year

    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, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety 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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