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

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

March 22, 2016

Primary Completion Date

August 22, 2016

Study Completion Date

August 22, 2016

Conditions
Healthy
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EirGenix, Inc.

INDUSTRY