Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:December 2015
End Date:July 2016
Contact:En Da Ko
Email:EnDa.Ko@celltrion.com
Phone:+82 32-850-6655

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind, Two-arm, Parallel-group, Single Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Two Formulations of Trastuzumab (CT-P6 and US-licensed Herceptin) in Healthy Subjects

This is a double-blind, two-arm, parallel-group, single-dose study.

This is a double-blind, two-arm, parallel-group, single-dose study. A total of 70 healthy
male subjects will be enrolled.

Inclusion Criteria:

1. Healthy male subject

2. Subject voluntarily agrees to participate in this study

Exclusion Criteria:

1. Female.

2. Subject has a medical condition of disease including one or more.

3. Smoker
We found this trial at
1
site
PPD Phase I Clinic
Austin, Texas 78744
Phone: 512-447-2985
?
mi
from
Austin, TX
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