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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Trastuzumab

Criteria

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