Healthy men needed to compare two injection methods for a cancer drug
NCT ID NCT07214766
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study checks if two different devices for injecting trastuzumab under the skin work the same way in the body. It involves 312 healthy men who will get a single dose. The goal is to see if the drug levels are similar, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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331 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Anaheim Clinical Trials
Anaheim, California, 92801, United States
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Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247, United States
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Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116, United States
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QPS Bio-Kinetic
Springfield, Missouri, 65802-4842, United States
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