H001-A2A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test

Fecha de inicio: 1 de septiembre de 2012

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.