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

NCT07214766
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Completed
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Participants
331
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Lead sponsor
Genentech, Inc.
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Start date
2025-10-17
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Number of sites
4
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Summary
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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Short title
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
clinicaltrials.gov
Official 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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-07-03
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First posted
2025-10-09
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Registry last updated
2026-07-17
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Primary completion date
2026-07-03
clinicaltrials.gov
Start date
2025-10-17
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Actual participants
331
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Participants
331
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
4
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Genentech, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07214766
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ClinicalTrials.gov ID
NCT07214766
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: Up to Day 57

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

    Timeframe: Up to Day 57

  3. Part 2: AUC0-21days of Trastuzumab

    Timeframe: Up to Day 57

  4. Part 2: Cmax of Trastuzumab

    Timeframe: Up to Day 57

  1. Percentage of Participants with Adverse Events (AEs)

    Timeframe: Up to Day 57

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults
Minimum age
18 Years
Maximum age
50 Years
Healthy volunteers
Yes

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical TrialsAnaheim, United States
  • Fortrea Clinical Research Unit - Daytona BeachDaytona Beach, United States
  • QPS Bio-KineticSpringfield, United States
  • Fortrea Clinical Research Unit - DallasDallas, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)