Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone

Inclusion Criteria:

- Male or female volunteers 18 to 60 years of age, inclusive.

- Intact normal skin in the area intended for administration.

- Adequate venous access in both upper extremities.

- Dental examination by an appropriately trained professional within 14 days of
administration demonstrating no signs, symptoms, or risk factors of osteonecrosis of
the jaw (ONJ).

- Vital signs (BP, HR, temperature, respiratory rate) within normal range or, if out of
range, assessed by the Investigator as not clinically significant and it is mutually
agreed by both Investigator and Sponsor Medical Monitor that the subject need not be
excluded from the study for this reason.

- Electrocardiogram within normal range or if out of range, assessed by the Investigator
as not clinically significant and it is mutually agreed by both Investigator and
Sponsor Medical Monitor that the subject need not be excluded from the study for this
reason.

- Within 14 days prior to administration, metabolic panel (e.g., sodium, potassium,
chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline
phosphatase, total bilirubin, albumin, and total protein) and complete blood count
within the laboratory normal reference range or, if out of range, assessed by the
Investigator as not clinically significant and it is mutually agreed by both
Investigator and Sponsor Medical Monitor that the subject need not be excluded from
the study for this laboratory value.

- A negative serum or urine pregnancy test (if female of child-bearing potential) within
14 days of study drug administration.

- Female subjects of child-bearing potential must agree to be currently practicing
effective birth control or abstinence and agree to continue to do so for at least 30
days after duration of their time on study.

- Decision-making capacity and willingness and ability to comply with the requirements
for full completion of the trial.

- Signed, written IRB/EC-approved informed consent.

Exclusion Criteria:

- Lower extremity edema.

- Lower extremity pathology that could interfere with any protocol-specified outcome
assessment (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain
syndrome, auxiliary lymph node dissection, etc.).

- Creatinine clearance < 60 mL/min (Cockcroft-Gault formula).

- Any risk factor for bisphosphonate-related renal toxicity including by not limited to
known predisposition to or history of renal insufficiency or renal failure,
hypertension, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and
subjects receiving known nephrotoxic drugs.

- Dehydration Grade 2 or higher based on NCI CTCAE V3.0.

- Known parathyroid gland dysfunction or any other disease that could lower blood
calcium levels.

- Known history and/or electrocardiographic evidence of atrial fibrillation.

- Known allergy to any hyaluronidase.

- Bisphosphonate treatment within preceding six months.

- Known allergy or intolerance to any bisphosphonate.

- Pregnancy or breast-feeding woman.

- Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological,
psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness
such as influenza, or other major systemic disease that would unduly risk the
subject's safety or interfere with the interpretation of results.

- Participation in a study of any investigational drug or device within 30 days of
enrollment in this study.