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Healthy men needed to compare two injection methods for a cancer drug

NCT ID NCT07214766

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

331 people

The number who actually took part.

Started

Oct 2025

Finished

Jul 2026

Lead sponsor

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

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

  • Fortrea Clinical Research Unit - Dallas

    Dallas, Texas, 75247, United States

  • Fortrea Clinical Research Unit - Daytona Beach

    Daytona Beach, Florida, 32117-5116, United States

  • QPS Bio-Kinetic

    Springfield, Missouri, 65802-4842, United States

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