NCT07214766

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Trastuzumab	Trastuzumab will be administered to participants as a solution for injection.

Timeline

• Start date: 2025-10-17
• Primary completion: 2026-04-15
• Completion: 2026-04-15
• First posted: 2025-10-09
• Last updated: 2026-04-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study