A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants

This Phase 1 study in healthy male volunteers is comparing two ways of delivering the cancer drug trastuzumab (used to treat HER2-positive breast cancer) under the skin: a handheld syringe or syringe pump with an infusion set versus a novel wearable on-body delivery system (OBDS) that allows patients to self-administer the drug at home. Researchers want to confirm that both devices deliver the same amount of drug into the body (bioequivalence) and assess their safety and tolerability. Healthy men with a BMI of 18–38 and body weight up to 100 kg, normal heart function (ejection fraction above 55%), and negative tests for hepatitis, HIV, and tuberculosis are eligible, while those with significant medical conditions, prior cancer treatments, cardiac history, or known sensitivity to the drug components are excluded. Participants will receive a single dose of trastuzumab via each delivery method in a crossover design, with blood samples collected to measure drug levels. This summary was prepared to help patients understand the study in plain language.