drugset / Trial / NCT04905667
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.
Timeline
- Start
- 2019-11-13
- Primary completion
- 2020-09-08
- Completion
- 2020-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GB221 | Monoclonal antibody | 6 mg/kg | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |