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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Trastuzumab

• Registration Number: NCT02665637
• Lead Sponsor: Celltrion

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-24
• Study First Posted: 2016-01-28
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P6	Trastuzumab	Trastuzumab
US-licensed Herceptin	Trastuzumab	Trastuzumab

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics will be assessed by AUC	up to week 10	Pharmacokinetics will be assessed by AUC.

Trial Locations

Locations (1)

PPD Phase I Clinic; 🇺🇸 Austin, Texas, United States