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

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02665637
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 17.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Trastuzumab	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: 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
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CT-P6 Trastuzumab	Drug: Trastuzumab; Each patient may receive single dose by intravenous infusion
Active Comparator: US-licensed Herceptin Trastuzumab	Drug: Trastuzumab; Each patient may receive single dose by intravenous infusion

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics will be assessed by AUC [up to week 10]

   Pharmacokinetics will be assessed by AUC.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Phase I Clinic	Austin	Texas	United States	78744

Sponsors and Collaborators

• Celltrion

Investigators

• Principal Investigator: Rebecca Wood-Horrall, MD, PPD Phase I Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT02665637
• Other Study ID Numbers: CT-P6 1.5
• First Posted: Jan 28, 2016
• Last Update Posted: Aug 26, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Trastuzumab

Study Results

No Results Posted as of Aug 26, 2016