Clinical trial NCT01689363: Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
Official title: A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Skin Reaction
Keywords: hyaluronidase
enzymes with tissue spreading activity
allergic reaction
intradermal skin testing
Lead sponsor: Amphastar Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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


Eligibility criteria: 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.

Primary outcomes:
measure: Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
Secondary outcomes:
measure: Observed Wheal Size in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Observed Erythema Size in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Allergic Wheal Size in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Allergic Erythema Size in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Local Itchiness Rate in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Erythema Responder Rate in the Per-Protocol Population (PPP)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Observed Wheal Size in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Observed Erythema Size in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Allergic Erythema Size in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Local Itchiness Rate in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Erythema Responder Rate in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
measure: Allergic Wheal Size in the Intent-to-Treat Population (ITT)
timeFrame: Up to 30 minutes after the final study drug injection
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Amphastar Site 0022
state: Oregon
city: Lake Oswego
country: United States
facility: Amphastar Site 0023
state: Oregon
city: Portland
country: United States
facility: Amphastar Site 0026
state: Oregon
city: Renton
country: United States
facility: Amphastar Site 0038
state: Washington
city: Seattle
country: United States
facility: Amphastar Site 0034
state: Washington
Study officials:
affiliation: A:mphastar Pharmaceuticals, Inc.
name: Selina Su, MPH
role: STUDY_CHAIR
References:
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citation: Brydon CW, Basler M, Kerr WJ. An evaluation of two concentrations of hyaluronidase for supplementation of peribulbar anaesthesia. Anaesthesia. 1995 Nov;50(11):998-1000. doi: 10.1111/j.1365-2044.1995.tb05940.x.
citation: Ahluwalia HS, Lukaris A, Lane CM. Delayed allergic reaction to hyaluronidase: a rare sequel to cataract surgery. Eye (Lond). 2003 Mar;17(2):263-6. doi: 10.1038/sj.eye.6700243. No abstract available.
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citation: Barbaud A, Reichert-Penetrat S, Trechot P, Jacquin-Petit MA, Ehlinger A, Noirez V, Faure GC, Schmutz JL, Bene MC. The use of skin testing in the investigation of cutaneous adverse drug reactions. Br J Dermatol. 1998 Jul;139(1):49-58. doi: 10.1046/j.1365-2133.1998.02313.x.
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citation: Ruzicka T, Gerstmeier M, Przybilla B, Ring J. Allergy to local anesthetics: comparison of patch test with prick and intradermal test results. J Am Acad Dermatol. 1987 Jun;16(6):1202-8. doi: 10.1016/s0190-9622(87)70158-3.