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

NCT02665637 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-08-26

No results posted yet for this study

Summary

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

Conditions

  • Healthy Volunteers

Interventions

DRUG

Trastuzumab

Each patient may receive single dose by intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Rebecca Wood-Horrall, MD · PPD Phase I Clinic

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02665637 on ClinicalTrials.gov