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

PHASE1CompletedINTERVENTIONAL
Enrollment

135

Participants

Timeline

Start Date

May 16, 2022

Primary Completion Date

January 24, 2023

Study Completion Date

January 24, 2023

Conditions
Breast Cancer
Interventions
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)

Trial Locations (1)

13353

CRS Clinical Research Services Berlin GmbH, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Sacura GmbH

OTHER

lead

EirGenix, Inc.

INDUSTRY