Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

Inclusion Criteria:

Healthy volunteers of either gender; Those without clinically significant cardiovascular
gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic
disease that would unduly risk the subject's safety or interfere with the interpretation
of results, assessed according to the judgment of the Principal Investigator. A
non-inclusive list which would not be exclusionary and define healthy individual for the
purposes of this study are:

- hypothyroidism,

- stable hypertension except those subjects on beta blockers including ocular
preparations,

- seasonal/perennial allergic rhinitis if able to wash out of antihistamines,

- stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an
as-needed basis, excluding daily usage),

- migraine if not taking excluded medications,

- mild anxiety/depression if not taking excluded medications, and

- mild arthritic conditions if not taking excluded medications.

- Willingness and ability to sign an informed consent document;

- 18 - 80 years of age;

- Intact skin at the forearm ;

- Female participants are currently practicing effective birth control methods or
abstinence.

Exclusion Criteria:

- Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal,
edetate disodium (EDTA);

- Use of medications within a duration considered to interfere with skin testing.

- Known dermographism which may interfere with skin testing.

- Pregnant or lactating women.