drugset / Trial / NCT05471648
A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.
Timeline
- Start
- 2022-05-16
- Primary completion
- 2023-01-24
- Completion
- 2023-01-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EG1206A | Unknown | 420 mg | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |