NCT05825781

Study, Evaluating Pharmacokinetics, Immunogenicity and Safety Profiles of Pertuzumab Compared to Perjeta® in Healthy Man

Randomized Double Blind Comparative Clinical Study Evaluating Pharmacokinetics and Safety in Single Intravenous Use of Pertuzumab (Manufactured by Mabscale, LLC) Compared to Perjeta® in Healthy Men

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Mabscale, LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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®.

Detailed description

Pertuzumab is a recombinant humanized monoclonal antibody currently being developed by Mabscale LLC, as a proposed biosimilar to Perjeta®, which is approved as treatment in patients with metastatic breast cancer in combination with trastuzumab and docetaxel and in patients with non-metastatic breast cancer in combination with trastuzumab and chemotherapy. This randomized equivalence study is designed to meet the regulatory requirement for approval of a biosimilar product.

Conditions

• Healthy Men

Interventions

Type	Name	Description
DRUG	Pertuzumab	i.v.
DRUG	Perjeta®	i.v.

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-01-22
• Completion: 2024-09-01
• First posted: 2023-04-24
• Last updated: 2024-08-16

Locations

1 site across 1 country: Russia