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

Purpose

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).

Condition

  • Healthy Participants

Eligibility

Eligible Ages
Between 18 Years and 50 Years
Eligible Sex
Male
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 		Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS.
  • Drug: Trastuzumab
    Trastuzumab will be administered to participants as a solution for injection.
Experimental
Part 2 		Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.
  • Drug: Trastuzumab
    Trastuzumab will be administered to participants as a solution for injection.

Recruiting Locations

Anaheim Clinical Trials
Anaheim 5323810, California 5332921 92801

Daytona Beach Clinical Rsch Unit
Daytona Beach 4152872, Florida 4155751 32117

QPS Bio-Kinetic
Springfield 4409896, Missouri 4398678 65802-4842

Fortrea Clinical Research Unit - Dallas
Dallas 4684888, Texas 4736286 75247

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GP44770 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com