Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: MSB11455; Drug: Neulasta

• Registration Number: NCT03251248
• Lead Sponsor: Fresenius Kabi SwissBioSim GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-16
• Study Start: 2017-08-22
• Primary Completion: 2018-05-08
• Study Completion: 2018-10-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First Neulasta Then MSB11455	MSB11455	-
First MSB11455 Then Neulasta	MSB11455	-
First MSB11455 Then Neulasta	Neulasta	-
First Neulasta Then MSB11455	Neulasta	-

Primary Outcome Measures

Name	Time	Method
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 Effect (Emax) for Absolute Neutrophil Count (ANC) 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
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

Name	Time	Method
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
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
Terminal Half-life (t1/2) 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
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

Trial Locations

Locations (2)

Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia

Q-Pharm Pty Ltd; 🇦🇺 Herston, Australia