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A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
Sponsor: Genentech, Inc.
Summary
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).
Official title: A Phase 1, Randomized, Two-Part, Parallel-Group Study to Assess the Bioequivalence of Subcutaneously Administered Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Subjects
Key Details
Gender
MALE
Age Range
18 Years - 50 Years
Study Type
INTERVENTIONAL
Enrollment
312
Start Date
2025-10-17
Completion Date
2026-04-15
Last Updated
2026-04-02
Healthy Volunteers
Yes
Conditions
Interventions
Trastuzumab
Trastuzumab will be administered to participants as a solution for injection.
Locations (4)
Anaheim Clinical Trials
Anaheim, California, United States
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, United States
QPS Bio-Kinetic
Springfield, Missouri, United States
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States