This two-part study will evaluate the bioequivalence, safety, and tolerability of a single SC dose of trastuzumab administered via handheld syringe/syringe pump (HHS/SP) with infusion set (IS) and an on-body delivery system (OBDS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
331
Trastuzumab will be administered to participants as a solution for injection.
Anaheim Clinical Trials
Anaheim, California, United States
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, United States
QPS Bio-Kinetic
Springfield, Missouri, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States
Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab
Time frame: Up to Day 57
Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab
Time frame: Up to Day 57
Part 2: AUC0-21days of Trastuzumab
Time frame: Up to Day 57
Part 2: Cmax of Trastuzumab
Time frame: Up to Day 57
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to Day 57
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