NCT05471648

A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers

Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) Sourced From US and EU Administered to Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: EirGenix, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This trial is part of a clinical development program developing a biosimilar pertuzumab, comparing the PK, safety and tolerability and immunogenicity of pertuzumab after a single intravenous (i.v.) infusion. It assess the bioequivalence, PK characteristics, safety and tolerability as well as the immunogenicity of a test preparation containing 420 mg pertuzumab (EG1206A EirGenix Pertuzumab) as compared to marketed reference (EU and US) after a single dose i.v. infusion over 60 minutes in fasted state.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection	Healthy volunteers receive pertuzumab (EG1206A, 420 mg, single dose)
DRUG	Perjeta (EU origin) 420 mg in 14 mL Injection	Healthy volunteers receive pertuzumab (Perjeta (EU origin) 420 mg, single dose)
DRUG	Perjeta (US origin) 420 mg in 14 mL Injection	Healthy volunteers receive pertuzumab (Perjeta (US origin), 420 mg, single dose)

Timeline

• Start date: 2022-05-16
• Primary completion: 2023-01-24
• Completion: 2023-01-24
• First posted: 2022-07-25
• Last updated: 2023-01-26

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study