A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-17

Study Completion Date

2026-04-15

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1

Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS.

Group Type EXPERIMENTAL

Trastuzumab

Intervention Type DRUG

Trastuzumab will be administered to participants as a solution for injection.

Part 2

Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.

Group Type EXPERIMENTAL

Trastuzumab

Intervention Type DRUG

Trastuzumab will be administered to participants as a solution for injection.

Interventions

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Trastuzumab

Trastuzumab will be administered to participants as a solution for injection.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes