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| Name | Class |
|---|---|
| Tri-Service General Hospital (TSGH) | OTHER |
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The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single-dose of UB-921 in healthy male volunteers.
This is an open-label, two-part, dose-escalation and comparative pharmacokinetics study of UB-921 in healthy male volunteers. There will be two parts: dose escalation study (Main Study) and comparative pharmacokinetics study (Sub-study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UB-921 2 mg/kg (Main-study) | Experimental | Intravenous infusion |
|
| UB-921 6 mg/kg (Main-study) | Experimental | Intravenous infusion |
|
| UB-921 8 mg/kg (Main-study) | Experimental | Intravenous infusion |
|
| UB-921 6 mg/kg (Sub-study) | Experimental | Intravenous infusion |
|
| Herceptin 6 mg/kg (Sub-study) | Active Comparator | Intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UB-921 | Biological | 150 mg/vial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event incidence | from the baseline to the end of study visit | 63 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hsiang-Cheng Chen | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prime site | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Herceptin | Biological | 440 mg/vial |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |