drugset / Trial / NCT03242239
A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects
Phase 1
Completed
105 enrolled
Alteogen, Inc.
Cristália Produtos Químicos Farmacêuticos Ltda. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.
Timeline
- Start
- 2016-02-09
- Primary completion
- 2016-08-04
- Completion
- 2016-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALT02 | Unknown | — | — |
| Comparator | Trastuzumab | Monoclonal antibody | — | — |
Indications
No indication recorded.