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NCT03251339 Clinical Trial

Safety and Immunogenicity of MSB11455 in Healthy Participants

Healthy Clinical Trial

Official title:
A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03251339
Other study ID # EMR200621-003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 21, 2017
Est. completion date September 22, 2018

Study information
Verified date March 2019
Source Fresenius Kabi SwissBioSim GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 336
Est. completion date September 22, 2018
Est. primary completion date February 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
New Zealand Auckland Clinical Studies Ltd Auckland
New Zealand Christchurch Clinical Studies Trust Christchurch

Sponsors (1)
Lead Sponsor Collaborator
Fresenius Kabi SwissBioSim GmbH

Country where clinical trial is conducted

New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary To Assess the Immunogenicity of MSB11455 Compared to Neulasta Immunogenicity assessment will be based on Antidrug Antibody (ADA) response and development of Neutralizing Antibodies (NAB) From first dose up to end of study (Up to 3 months)
Secondary Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs) Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs Day 1 up to a maximum of 1 year
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