NCT03180242

A Pharmacokinetic Study Comparing EG12014 and Herceptin (Trastuzumab) in Healthy Male Volunteers

Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Two-Stage, Comparative Pharmacokinetic Study of EirGenix' Trastuzumab and Herceptin® (Trastuzumab) Sourced From US and EU Administered to Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: EirGenix, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this trial is to assess the pharmacokinetic similarity of EG12014 (Test IMP) compared to reference products sourced from the European Union (Reference IMP 1: Herceptin® 150 mg powder for concentrate for solution for infusion) and the United States (Reference IMP 2: Herceptin® 440 mg powder for concentrate for solution for infusion) after intravenous infusion over 90 minutes of a single dose of 6 mg/kg trastuzumab in 3 parallel groups of healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	EG12014	EG12014, single-dose IV infusion over 90 min at 6 mg/kg
BIOLOGICAL	EU-sourced Herceptin	EU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
BIOLOGICAL	US-sourced Herceptin	US-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg

Timeline

• Start date: 2016-03-22
• Primary completion: 2016-08-22
• Completion: 2016-08-22
• First posted: 2017-06-08
• Last updated: 2017-06-08