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

NCT05471648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2023-01-26

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Sacura GmbH

    collaborator OTHER

  • EirGenix, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthias Berse, Dr. med. · CRS Clinical Research Services Berlin GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2023-01-24
Completion
2023-01-24
FDA Drug
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05471648 on ClinicalTrials.gov