A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
- Registration Number
- NCT07214766
- Lead Sponsor
- Genentech, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 312
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Trastuzumab Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS. Part 2 Trastuzumab Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.
- Primary Outcome Measures
Name Time Method Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab Up to Day 57 Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab Up to Day 57 Part 2: AUC0-21days of Trastuzumab Up to Day 57 Part 2: Cmax of Trastuzumab Up to Day 57 Percentage of Participants with Adverse Events (AEs) Up to Day 57
- Secondary Outcome Measures
Name Time Method