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

NCT03180242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-06-08

No results posted yet for this study

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

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 & Collaborators

  • EirGenix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-03-22
Primary Completion
2016-08-22
Completion
2016-08-22

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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 NCT03180242 on ClinicalTrials.gov