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

NCT07214766 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2026-05-20

No results posted yet for this study

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

DRUG

Trastuzumab

Trastuzumab will be administered to participants as a solution for injection.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-17
Primary Completion
2026-07-03
Completion
2026-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214766 on ClinicalTrials.gov