Assessing the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses Neulasta®

Phase 1 Completed 303 enrolled Coherus Oncology, Inc.

RandomizedParallel-groupTriple-blind

Summary

This is a randomized, double-blind, 2-period parallel study in healthy subjects to assess immunogenicity and safety of two sequential 6 mg subcutaneous (SC) injections of CHS-1701 compared with two sequential 6 mg SC injections of Neulasta®.

Timeline

Start: 2015-05
Primary completion: 2015-12
Completion: 2015-12

Publications

Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CHS-1701	Unknown	6 mg	Subcutaneous
Comparator	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications

No indication recorded.