A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms… (NCT07214766) | Clinical Trial Compass
RecruitingPhase 1
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
United States312 participantsStarted 2025-10-17
Plain-language 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).
Who can participate
Age range18 Years – 50 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
What they're measuring
1
Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab
Timeframe: Up to Day 57
2
Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab
Timeframe: Up to Day 57
3
Part 2: AUC0-21days of Trastuzumab
Timeframe: Up to Day 57
4
Part 2: Cmax of Trastuzumab
Timeframe: Up to Day 57
Trial details
NCT IDNCT07214766
SponsorGenentech, Inc.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2026-07-05
Contact for this trial
Reference Study ID Number: GP44770 https://forpatients.roche.com/