Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251248
• Other study ID #: EMR200621-001
• Status: Completed
• Phase: Phase 1
• Start date: August 22, 2017
• Est. completion date: October 17, 2018

Study information

• Verified date: January 2019
• Source: Fresenius Kabi SwissBioSim GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: October 17, 2018
• Est. primary completion date: May 8, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MSB11455
Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.
• Neulasta
Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Herston
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi SwissBioSim GmbH

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Primary	Maximum Observed Effect (Emax) for Absolute Neutrophil Count (ANC) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Primary	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	Time to Maximum Observed Plasma Concentration (tmax) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Secondary	Time to Last Observed Plasma Concentration (tlast) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Secondary	Terminal rate constant (?z) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Secondary	Terminal Half-life (t1/2) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Secondary	Apparent Total Plasma Clearance (CL/F) of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Secondary	Time to Maximum Observed Effect (tEmax) for ANC of MSB11455 and Neulasta		Pre-dose up to 15 days post-dose
Secondary	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
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 15 months