Risk Factors for or a Diagnosis of Osteoporosis Clinical Trial
Official title:
Phase I, Open-Label, Pharmacokinetic, Safety and Tolerability Study of Subcutaneously Administered Bisphosphonate With Recombinant Human Hyaluronidase (rHuPH20) vs Bisphosphonate
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.
n/a