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This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.
The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylenex | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The time to inject 20 mL of a viscous antibody solution with and without rHuPH20. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anoshie Ratnayake, M.D. | Principal Investigator | Principal Investigator |
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