drugset / Trial / NCT04601389
Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Omalizumab | Monoclonal antibody | 150 mg | Subcutaneous |
Indications
No indication recorded.