Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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).
Protocol Amendment History 5 changes
critical Trial completed 2026-07-19
critical Trial status changed: RECRUITING → ACTIVE_NOT_RECRUITING 2026-05-21
critical Primary endpoint(s) modified 2026-05-01
notable Primary completion pushed: 2026-04-15 -> 2026-07-05 2026-05-01
minor Completion pushed: 2026-04-15 -> 2026-07-05 2026-05-01
Trial Details
NCT Number NCT07214766
Lead Sponsor Genentech, Inc.
Conditions Healthy Participants
Enrollment 331 participants
Start Date 2025-10-17
Primary Completion 2026-07-03 (estimated)
Study Completion 2026-07-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-17