drugset / Trial / NCT04601389

Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®

NCT04601389

Phase 1 Completed 84 enrolled AO GENERIUM
RandomizedParallel-groupOpen-labelOther

Summary

An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in healthy volunteers at 150 mg

Timeline

Start
2017-04-18
Primary completion
2017-09-06
Completion
2017-09-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Omalizumab Monoclonal antibody 150 mg Subcutaneous

Indications

No indication recorded.