Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SB3

SB3, single dose of 6 mg/kg via intravenous infusion (study drug)

Group Type EXPERIMENTAL

SB3

Intervention Type BIOLOGICAL

EU sourced Herceptin®

EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)

Group Type ACTIVE_COMPARATOR

EU sourced Herceptin®

Intervention Type BIOLOGICAL

US sourced Herceptin®

US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)

Group Type ACTIVE_COMPARATOR

US sourced Herceptin®

Intervention Type BIOLOGICAL

Interventions

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SB3

Intervention Type BIOLOGICAL

EU sourced Herceptin®

Intervention Type BIOLOGICAL

US sourced Herceptin®

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes