drugset / Trial / NCT05471648

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

NCT05471648

Phase 1 Completed 135 enrolled EirGenix, Inc. Sacura GmbH · collab
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

EvaluationDrugModalityDoseRoute
Subject EG1206A Unknown 420 mg Intravenous
Comparator Pertuzumab Monoclonal antibody 420 mg Intravenous

Indications