Trials / Completed
CompletedNCT00807963
Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
Phase I, Open-Label, Pharmacokinetic, Safety and Tolerability Study of Subcutaneously Administered Bisphosphonate With Recombinant Human Hyaluronidase (rHuPH20) vs Bisphosphonate
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Halozyme Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rHuPH20 | recombinant human hyaluronidase PH20 injection |
| DRUG | zoledronic acid | subcutaneous injection |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2009-09-21
- Completion
- 2009-09-21
- First posted
- 2008-12-15
- Last updated
- 2018-08-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00807963. Inclusion in this directory is not an endorsement.