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

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.

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.