Healthy ParticipantsPhase 1NCT07214766
A Study to Assess the Bioequivalence of Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Participants
A Phase 1 study testing Trastuzumab in people with Healthy Participants, run by Genentech, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Oct 2025to 3 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Fortrea Clinical Research Unit - Dallas
Dallas, Texas, 75247
Fortrea Clinical Research Unit - Daytona Beach
Daytona Beach, Florida, 32117-5116
QPS Bio-Kinetic
Springfield, Missouri, 65802-4842
About this study
Official title: 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
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
- Being tested
- Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Trastuzumab will be administered to participants as a solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS. Receives: Drug: Trastuzumab |
| Part 2 | Experimental | Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab
Measured: Up to Day 57
Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab
Measured: Up to Day 57
Part 2: AUC0-21days of Trastuzumab
Measured: Up to Day 57
Part 2: Cmax of Trastuzumab
Measured: Up to Day 57
Secondary outcomes (1)
Percentage of Participants with Adverse Events (AEs)
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start17 Oct 2025
- Primary completion3 Jul 2026
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214766
- Sponsor's protocol ID
- GP44770
- Status last verified
- Jul 2026
- First submitted
- 6 Oct 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07214766
- Acronym / sponsor ID
- GP44770
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: TrastuzumabParticipants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS. |
| Part 2 | Experimental | Drug: TrastuzumabParticipants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabTrastuzumab will be administered to participants as a solution for injection. | Drug | Part 1, Part 2 |
Primary outcome
Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab
Time frame: Up to Day 57
Part 1: Maximum Observed Concentration (Cmax) of Trastuzumab
Time frame: Up to Day 57
Part 2: AUC0-21days of Trastuzumab
Time frame: Up to Day 57
Part 2: Cmax of Trastuzumab
Time frame: Up to Day 57
1 secondary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trastuzumab in people with Healthy Participants, run by Genentech, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Area Under the Concentration-Time Curve from Hour 0 to 21 days Postdose (AUC0-21days) of Trastuzumab (time frame: Up to Day 57). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.