A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
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).
Key facts
- Study ID
- NCT07214766
- Run by
- Genentech, Inc.
- People needed
- 331
- Starts
- 2025-10-17
- Expected to finish
- 2026-07-03
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Anaheim Clinical Trials — Anaheim, California, United States
- Fortrea Clinical Research Unit - Daytona Beach — Daytona Beach, Florida, United States
- QPS Bio-Kinetic — Springfield, Missouri, United States
- Fortrea Clinical Research Unit - Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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