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The purpose of this study is to determine the maximum tolerated concentration (MTC) of bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20 to bisphosphonate alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1: rHuPH20 plus ZA | Experimental | Participants will receive one of several dose/concentrations of recombinant human hyaluronidase PH20 (rHuPH20) with zoledronic acid (ZA). |
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| Stage 2: ZA | Experimental | Participants will receive a dose/concentration of ZA administered without rHuPH20. |
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| Stage 3: rHuPH20 plus ZA | Experimental | Participants will receive one of several dose/concentrations of rHuPH20 with ZA. |
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| Stage 4: ZA | Experimental | Participants will receive an intravenous (IV) dose of 5 milligrams (mg) ZA. |
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| Stage 4: ZA with rHuPH20 | Experimental | Participants will receive a subcutaneous (SC) dose of ZA with rHuPH20. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rHuPH20 | Drug | recombinant human hyaluronidase PH20 injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of local tolerability of injected drug product | Over a 7 day period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emanuel P DeNoia, MD | Healthcare Discoveries, LLC/ICON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, LLC/ICON Development Solutions | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| zoledronic acid | Drug | subcutaneous injection |
|
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |