drugset / Trial / NCT05825781
Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man
RandomizedParallel-groupDouble-blindOther
Summary
PERT-1/12102020 is a double-blind randomized single-center clinical trial comparing pharmacokinetics, immunogenicity and safety profiles of Pertuzumab (manufactured by Mabscale, LLC) compared to Perjeta® in healthy men. The purpose of the study is to demonstrate equivalence of pharmacokinetics, immunogenicity and safety of Pertuzumab (manufactured by Mabscale, LLC) to Perjeta®.
Timeline
- Start
- 2023-07-20
- Primary completion
- 2024-01-22
- Completion
- 2024-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Pertuzumab | Monoclonal antibody | 420 mg | Intravenous |
Indications
No indication recorded.