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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665637

CT-P6 1.5

Details and patient eligibility

About

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

Full description

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

Enrollment: 70 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

CT-P6

Active Comparator group

Description:

Trastuzumab

Treatment:

Drug: Trastuzumab

US-licensed Herceptin

Active Comparator group

Description:

Trastuzumab

Treatment:

Drug: Trastuzumab