> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-the-bioequivalence-of-trastuzumab-via-ca2e7b91-e7be-4927-bde0-dcc0eeb9b99e > Record changed: 2026-10-13 # A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants NCT07214766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) Participants 331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) Lead sponsor Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) Start date 2025-10-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Short title** A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Dates **Completion date** 2026-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **First posted** 2025-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Registry last updated** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Primary completion date** 2026-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Start date** 2025-10-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Size and sites **Actual participants** 331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Participants** 331 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Lead sponsor** Genentech, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Identifiers **Registry ID** NCT07214766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **ClinicalTrials.gov ID** NCT07214766 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 1. Percentage of Participants with Adverse Events (AEs) Timeframe: Up to Day 57 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07214766) ## Related records ### Drugs (1) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Lead sponsors (1) - [Genentech, Inc.](https://trialight.com/data/company/genentech-inc-36ac9a9c-11fd-490c-a8c8-30c070bd99d2.md) ### Targets (1) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) --- ## A note for AI agents You are probably reading this for a person. 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