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

  • Germany
      • Berlin, Germany
        • Samsung Investigational Site

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)
Biological: SB3
Active Comparator: EU sourced Herceptin®
EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
Biological: EU sourced Herceptin®
Active Comparator: US sourced Herceptin®
US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)
Biological: US sourced Herceptin®

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
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

Samsung Bioepis Co., Ltd.

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.

General Publications

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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