Healthy Participants
Conditions
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).
Interventions
DRUGTrastuzumab
Trastuzumab will be administered to participants as a solution for injection.
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to Day 57 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed