Status:
RECRUITING
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
Lead Sponsor:
Genentech, Inc.
Conditions:
Healthy Participants
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Within body mass index (BMI) range 18 to 38 kilogram per meter square (kg/m2), inclusive. Body weight \<=100 kg
- Left ventricular ejection fraction (LVEF) \>= 55 percent (%) measured by echocardiogram (ECHO)
- Negative test result for drugs of abuse
- Negative test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen
- Negative test for latent Tuberculosis (TB) infection by QuantiFERON® TB Gold
- Agree to use contraception and will refrain from sperm donation
Exclusion
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, respiratory, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease
- History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins
- Known sensitivity to recombinant hyaluronidase or other form of hyaluronidase
- History or presence of atrial fibrillation
- History of any clinically significant or clinically relevant cardiac condition
- History or presence of clinically significant electrocardiogram (ECG) abnormalities
- History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes
- Family history of clinically significant and clinically relevant hypersensitivity, allergy, or severe cardiac diseases
- History of previous anti-cancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs
- History of active or latent TB, regardless of treatment history
- Poor peripheral venous access
- History or presence of any malignancy, with the exception of completely excised basal cell or squamous cell carcinoma of the skin
Key Trial Info
Start Date :
October 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2026
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT07214766
Start Date
October 17 2025
End Date
April 15 2026
Last Update
January 7 2026
Active Locations (4)
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1
Anaheim Clinical Trials
Anaheim, California, United States, 92801
2
Daytona Beach Clinical Rsch Unit
Daytona Beach, Florida, United States, 32117
3
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802-4842
4
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, United States, 75247