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

NCT07214766 | Recruiting Phase 1 FDA Drug

• 1 other identifier: GP44770
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 4

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).

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Percentage of Participants with Adverse Events (AEs)

  Up to Day 57

Study Arms (2)

Part 1

EXPERIMENTAL

Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS.

Drug: Trastuzumab

Part 2

EXPERIMENTAL

Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS.

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

Trastuzumab will be administered to participants as a solution for injection.

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (4)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

RECRUITING

Daytona Beach Clinical Rsch Unit

Daytona Beach, Florida, 32117, United States

RECRUITING

QPS Bio-Kinetic

Springfield, Missouri, 65802-4842, United States

RECRUITING

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247, United States

RECRUITING

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: GP44770 https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)