Pharmacokinetic/Pharmacodynamic Equivalence of MSB11455 in Healthy Subjects

Summary

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

Timeline

Start

2017-08-22

Primary completion

2018-05-08

Completion

2018-10-17

Outcome

Met primary endpoint

paper 90% repeated confidence intervals of geometric means ratio of MSB11455 to the reference product were within the pre-defined equivalence range (80.00%-125.00%) for AUC0-∞ (96.59-112.82) PMID 32660769 ↗

paper Pharmacokinetic and pharmacodynamic equivalence of MSB11455 and the reference product was shown PMID 32660769 ↗

Publications

• Lickliter J, Kanceva R, Vincent E, Schueler A, Harrison-Moench E, Yue CS, Stahl M, Ullmann M, Ghori V, Griffin P. Pharmacokinetics and Pharmacodynamics of a Proposed Pegfilgrastim Biosimilar MSB11455 Versus the Reference Pegfilgrastim Neulasta in Healthy Subjects: A Randomized, Double-blind Trial. Clin Ther. 2020 Aug;42(8):1508-1518.e1. doi: 10.1016/j.clinthera.2020.05.020. Epub 2020 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MSB11455	Unknown	6 mg	Subcutaneous
Subject	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications

No indication recorded.