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

Completed · Phase 2

Conditions studied: Allergic Skin Reaction

In brief

This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.

Key facts

Study ID

NCT01689363

Run by

Amphastar Pharmaceuticals, Inc.

People needed

253

Starts

2012-09-01

Expected to finish

2012-12-01

Last updated by the study team

2017-01-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Amphastar Site 0022 — Eugene, Oregon, United States
• Amphastar Site 0023 — Lake Oswego, Oregon, United States
• Amphastar Site 0026 — Portland, Oregon, United States
• Amphastar Site 0038 — Renton, Washington, United States
• Amphastar Site 0034 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.