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RECRUITING
NCT07214766
PHASE1

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

Sponsor: Genentech, Inc.

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).

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

Interventions

DRUG

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