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OpenTrials
Completed

NCT Number: NCT07214766

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

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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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

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

Primary outcomes

  1. Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab

    Time frame: Up to Day 57

  2. Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab

    Time frame: Up to Day 57

  3. Part 2: AUC0-21days of Trastuzumab

    Time frame: Up to Day 57

  4. Part 2: Cmax of Trastuzumab

    Time frame: Up to Day 57

Secondary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: Up to Day 57

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Two-Part, Parallel-Group Study to Assess the Bioequivalence of Subcutaneously Administered Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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