Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
NCT ID: NCT02665637
Last Updated: 2016-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
70 participants
INTERVENTIONAL
2015-12-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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CT-P6
Trastuzumab
Trastuzumab
Each patient may receive single dose by intravenous infusion
US-licensed Herceptin
Trastuzumab
Trastuzumab
Each patient may receive single dose by intravenous infusion
Interventions
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Trastuzumab
Each patient may receive single dose by intravenous infusion
Eligibility Criteria
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Inclusion Criteria
2. Subject voluntarily agrees to participate in this study
Exclusion Criteria
2. Subject has a medical condition of disease including one or more.
3. Smoker
18 Years
55 Years
MALE
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Wood-Horrall, MD
Role: PRINCIPAL_INVESTIGATOR
PPD Phase I Clinic
Locations
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PPD Phase I Clinic
Austin, Texas, United States
Countries
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Other Identifiers
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CT-P6 1.5
Identifier Type: -
Identifier Source: org_study_id
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