drugset / Trial / NCT05864261

Pharmacokinetics Comparison Study of JT1801 and NESP® After Single Dose Administration in Chinese Health Male Volunteers

NCT05864261

Phase 4 Completed 74 enrolled Yi Fang
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the similarity of major pharmacokinetic parameters after a single intravenous administration of JT1801 and NESP® in chinese healthy male volunteers. And to evaluate the safety, immunogenicity and pharmacodynamic characteristics of JT1801 and NESP® in chinese healthy male volunteers

Timeline

Start
2023-05-15
Primary completion
2023-08-28
Completion
2023-08-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darbepoetin alfa Protein / enzyme biologic 60 ug Intravenous
Subject JT1801 Unknown 60 ug Intravenous

Indications