- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02075073
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
August 16, 2017 updated by: Samsung Bioepis Co., Ltd.
A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Trastuzumab (SB3, EU Sourced Herceptin® and US Sourced Herceptin®) in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
109
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany
- Samsung Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects
- Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and 29.9 kg/m², inclusive.
Exclusion Criteria:
- history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus), psychiatric or significant allergic disease excluding mild asymptomatic allergies.
- history of and/or current cardiac disease
- previously received any monoclonal antibody or fusion protein.
- history of cancer including lymphoma, leukaemia and skin cancer.
- Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
- intake medication with a half-life > 24 h within 1 month or 10 half-lives of the medication prior to the administration of investigational product.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SB3
SB3, single dose of 6 mg/kg via intravenous infusion (study drug)
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Active Comparator: EU sourced Herceptin®
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
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Active Comparator: US sourced Herceptin®
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
Time Frame: 57 days
|
57 days
|
Maximum Serum Concentration (Cmax)
Time Frame: 57 days
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57 days
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
Time Frame: 57 days
|
57 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Cmax (Tmax)
Time Frame: 57 days
|
57 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Saumsung Bioepis, Samsung Bioepis Co., Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 27, 2014
First Submitted That Met QC Criteria
February 27, 2014
First Posted (Estimate)
March 3, 2014
Study Record Updates
Last Update Posted (Actual)
September 14, 2017
Last Update Submitted That Met QC Criteria
August 16, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SB3-G11-NHV
- 2013-004112-21 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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