Trial Profile
A Randomized, Single-Blind, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Bioequivalence of CHS-1701 (Coherus Pegfilgrastim) With Neulasta in Healthy Subjects
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 24 Jan 2022
Price :
$35
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At a glance
- Drugs Pegfilgrastim (Primary)
- Indications Neutropenia
- Focus Pharmacodynamics; Pharmacokinetics; Registrational
- Sponsors Coherus Biosciences
- 16 Jan 2022 Results of a pooled analysis (NCT02418104, NCT02650973 and NCT02385851) assessing the similar immunogenicity of pegfilgrastim-cbqv and pegfilgrastim published in the Advances in Therapy
- 13 Aug 2020 Primary endpoint (ANC AUC from time 0 to the last measurable observation (ANC AUC0last).) has been met, as per Results published in the Advances in Therapy
- 13 Aug 2020 Primary endpoint (maximum absolute neutrophil count (ANCmax)) has been met, as per Results published in the Advances in Therapy