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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02665637

Enrollment

Registered

2016-01-28

Start date

2015-12-31

Completion date

2016-04-30

Last updated

2016-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGTrastuzumab

Each patient may receive single dose by intravenous infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics will be assessed by AUC	up to week 10	Pharmacokinetics will be assessed by AUC.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026