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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Biological: SB3
* Biological: EU sourced Herceptin®
* Biological: US sourced Herceptin®


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB3<br>SB3, single dose of 6 mg/kg via intravenous infusion (study drug) | Biological: SB3<br> <br> |
| Active Comparator: EU sourced Herceptin®<br>EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) | Biological: EU sourced Herceptin®<br> <br> |
| Active Comparator: US sourced Herceptin®<br>US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug) | Biological: US sourced Herceptin®<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) |  | 57 days | 
| Maximum Serum Concentration (Cmax) |  | 57 days | 
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |  | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cmax (Tmax) |  | 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics