Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03251248

Enrollment

294

Registered

2017-08-16

Start date

2017-08-22

Completion date

2018-10-17

Last updated

2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

MSB11455, Healthy subjects

Brief summary

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

Interventions

DRUGMSB11455

Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.

DRUGNeulasta

Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta	Pre-dose up to 15 days post-dose	—
Time to Maximum Observed Plasma Concentration (tmax) 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)	Day 1 up to a maximum of 15 months	Safety assessment will be based on number of subjects with AEs, abnormal laboratory variables, abnormal vital signs, incidence of ADAs and NABs
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	—
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	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026