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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Participants will receive formulation 1 of trastuzumab SC via OBDS or HHS/SP with IS. |
|
| Part 2 | Experimental | Participants will receive formulation 2 of trastuzumab SC via OBDS or HHS/SP with IS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab | Drug | Trastuzumab will be administered to participants as a solution for injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Up to Day 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | United States | ||
| Daytona Beach Clinical Rsch Unit |
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| Daytona Beach |
| Florida |
| 32117 |
| United States |
| QPS Bio-Kinetic | Springfield | Missouri | 65802-4842 | United States |
| Fortrea Clinical Research Unit - Dallas | Dallas | Texas | 75247 | United States |
| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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