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OpenTrials
Completed

NCT Number: NCT02665637

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78744, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subject
  • Subject voluntarily agrees to participate in this study

Exclusion criteria

  • Female.
  • Subject has a medical condition of disease including one or more.
  • Smoker

Treatment and study plan

Trastuzumab

Drug

Each patient may receive single dose by intravenous infusion

Primary outcomes

  1. Pharmacokinetics will be assessed by AUC

    Time frame: up to week 10

    Pharmacokinetics will be assessed by AUC.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2016
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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