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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
119
600 mg subcutaneously using a single-use injection device on Day 1
600 mg subcutaneously using a handheld syringe on Day 1
Unnamed facility
Christchurch, New Zealand
Unnamed facility
Grafton, New Zealand
Area under plasma concentration curve of trastuzumab
Time frame: 21 days
Maximum observed plasma concentration of trastuzumab
Time frame: 21 days
Plasma concentration of trastuzumab
Time frame: Day 21
Safety: Incidence of adverse events
Time frame: 21 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.