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
Genentech, Inc.
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).
Eligibility
- Age range
- 18–50 years
- Sex
- Male
- 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…
Interventions
- DrugTrastuzumab
Trastuzumab will be administered to participants as a solution for injection.
Locations (4)
- Anaheim Clinical TrialsAnaheim, California
- Daytona Beach Clinical Rsch UnitDaytona Beach, Florida
- QPS Bio-KineticSpringfield, Missouri
- Fortrea Clinical Research Unit - DallasDallas, Texas