Actively Recruiting
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
Led by Genentech, Inc. · Updated on 2026-04-30
312
Participants Needed
4
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 50 years
- Body mass index (BMI) between 18 and 38 kg/m2, inclusive, with body weight 100 kg or less
- Left ventricular ejection fraction (LVEF) of 55% or higher measured by echocardiogram
- Negative test results for drugs of abuse
- Negative test results for hepatitis B surface antigen, hepatitis C virus, and HIV antibody screen
- Negative test for latent tuberculosis infection by QuantiFERON TB Gold
- Agree to use contraception and refrain from sperm donation
You will not qualify if you...
- Significant history or symptoms of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, respiratory, gastrointestinal, immunological, neurological, or psychiatric disorders
- Acute infections or unstable medical diseases
- History of moderate or severe allergic or hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- Known sensitivity to recombinant hyaluronidase or other forms of hyaluronidase
- History or presence of atrial fibrillation
- History of clinically significant cardiac conditions or ECG abnormalities
- History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes
- Family history of severe allergy, hypersensitivity, or cardiac diseases
- Previous anti-cancer treatments including pertuzumab, trastuzumab, anthracyclines, or cardiotoxic drugs
- History of active or latent tuberculosis
- Poor peripheral venous access
- History or presence of any malignancy except fully excised basal or squamous cell carcinoma of the skin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Actively Recruiting
2
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, United States, 32117
Actively Recruiting
3
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802-4842
Actively Recruiting
4
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247
Actively Recruiting
Research Team
R
Reference Study ID Number: GP44770 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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