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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.