Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: MSB11455
* Drug: Neulasta


Participation Criteria
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Eligibility Criteria
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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.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First MSB11455 Then Neulasta<br> | Drug: MSB11455<br>* Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.<br>Drug: Neulasta<br>* Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.<br>* Other names: pegfilgrastim;|
| Experimental: First Neulasta Then MSB11455<br> | Drug: MSB11455<br>* Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.<br>Drug: Neulasta<br>* Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.<br>* Other names: pegfilgrastim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| Terminal rate constant (λz) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| Terminal Half-life (t1/2) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta |  | Pre-dose up to 15 days post-dose | 
| 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 | 
| 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 15 months | 

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