A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe

A Randomized, Open-label, 2-arm, Parallel Group, Single Dose, Multi-center Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of Trastuzumab Administered Subcutaneously as the Trastuzumab/rHuPH20 Formulation Using a Handheld Syringe or Using the Proprietary Single-use Injection Device (SID)

This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.

Inclusion Criteria:

• Healthy male patients, 18 to 45 years of age, inclusive
• No history of hypersensitivity or allergic reactions following drug administration
• No history of clinically significant or clinically relevant cardiac condition
• No history of previous anticancer treatment
• Body mass index (BMI) between 18-32 kg/m2, inclusive

Exclusion Criteria:

• Positive test result for drugs of abuse
• Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
• Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
• Clinically significant abnormal laboratory values