Safety and Immunogenicity of MSB11455 in Healthy Participants

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

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MSB11455
* Drug: US-Neulasta


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSB11455<br>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<br>* 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.<br>|
| Experimental: US-Neulasta<br>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<br>* 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.<br>* Other names: pegfilgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Participants, MSB11455