drugset / Trial / NCT04820439
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
RandomizedParallel-groupOpen-labelOther
Summary
This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
Timeline
- Start
- 2020-10-13
- Primary completion
- 2021-02-01
- Completion
- 2021-03-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HS627 | Monoclonal antibody | 420 mg | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
Indications
No indication recorded.